European Union: European Medicines Agency (EMA): Recommends Approval Of Sixteen Medicines In Its July Meeting

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended sixteen medicines for approval, including two orphan medicines, three new Biosimilars, three new generic drugs and one hybrid drug, at its July 2018 meeting1.

  1. The sixteen medicines recommended for approval are:

Sl. No.

Name of Medicine

Indicated For

Marketing-Authorisation Holder

1

Braftovi (encorafenib)

In combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation

Pierre Fabre Medicament

2

Ilumetri (tildrakizumab)

Treatment of moderate to severe plaque psoriasis

Almirall S.A.

3

Imfinzi (durvalumab)

Treatment of non-small cell lung cancer

AstraZeneca AB

4

Mektovi (binimetinib)

In combination with encorafenib, is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation

Pierre Fabre Medicament

5

Onpattro (patisiran)

Treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy (a condition in which the peripheral nerves are damaged).

- hATTR amyloidosis is an inherited, rare, life-threatening disease. It is caused by mutations in the transthyretin (TTR) gene that result in misfolded TTR proteins accumulating as amyloid fibrils in multiple sites, including the nerves, heart and gastrointestinal tract. Patients with this condition usually have heart problems and symptoms such as muscle weakness in the limbs and, at later stages, inability to walk, problems affecting the stomach and the gut (leading to malnutrition), and bladder dysfunction. hATTR amyloidosis is more frequent in men than women2.

Alnylam Netherlands B.V.

6

Slenyto (melatonin)

Treatment of insomnia in children from 2 years of age with autism spectrum disorder and Smith-Magenis syndrome (a disorder with a variety of features including intellectual disability, speech and language delay, distinctive facial features, difficulty sleeping and behavioural problems).

RAD Neurim Pharmaceuticals EEC Ltd.

7

Symkevi (tezacaftor / ivacaftor)

Treatment of cystic fibrosis

Vertex Pharmaceuticals (Europe) Ltd.

8

Verzenios (abemaciclib)

Treatment of locally advanced or metastatic breast cancer

Eli Lilly Nederland B.V.

9

Xerava (eravacycline)

Treatment of complicated intra-abdominal infections in adults

Tetraphase Pharmaceuticals Ireland Limited

10

Deferiprone Lipomed (deferiprone)

Treatment of iron overload in patients with thalassemia major

Lipomed GmbH

11

Gefitinib Mylan (gefitinib)

Treatment of non-small cell lung cancer

Mylan S.A.S.

12

Lenalidomide Accord (lenalidomide)

Treatment of multiple myeloma

Accord Healthcare Limited

13

Hulio (adalimumab)

Treatment of certain inflammatory and autoimmune disorders

Mylan S.A.S

14

Pelgraz (pegfilgrastim)

Intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy

Accord Healthcare Limited

15

Udenyca (pegfilgrastim)

Intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy

ERA Consulting GmbH

16

Kigabeq (vigabatrin)

Treatment of infantile spasms (West's syndrome), an uncommon and severe form of epilepsy associated with a highly-resistant seizure type (epileptic spasms) and a rapid psychomotor regression, and in resistant partial epilepsy, in infants and children from 1 month to 7 years of age3.

Orphelia Pharma SAS

  1.    Negative recommendations on new medicines following re-examination

The CHMP's re-examined the negative recommendation for two drugs Dexxience (betrixaban) and Eladynos (abaloparatide). The applicants requested re-examination of the Committee's negative opinions for these medicines adopted at its March 2018 meeting. After considering the grounds for these requests, the CHMP re-examined the initial opinions and confirmed its previous recommendations to refuse the granting of marketing authorizations for these medicines. The applicant for Dexxience is Portola Pharma UK Limited, and for Eladynos applicant is Radius International Ltd.

  1. Twelve recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for twelve medicines - Abseamed, Binocrit, Blincyto, Darzalex, Epoetin alfa Hexal, Kalydeco, Mekinist, Nucala, Tafinlar, Xarelto and two extensions of indication for Keytruda.

  1. Negative opinions on extension of therapeutic indication

The CHMP adopted a negative opinion for the use of Opdivo (nivolumab) and Yervoy (ipilimumab) in combination to treat renal cell carcinoma (kidney cancer). The Committee also adopted a negative opinion for an extension of therapeutic indication for Blincyto in patients with minimal residual disease after treatment for B-precursor acute lymphoblastic leukaemia.

  1. Outcome of review on Xofigo

The CHMP recommended restricting the use of Xofigo (radium-223 dichloride) in patients who have had two previous treatments for metastatic prostate cancer or who cannot receive other treatments.

Xofigo must also not be used with the medicines Zytiga (abiraterone acetate) and the corticosteroid prednisone or prednisolone. Xofigo should not be used with other systemic cancer therapies, except for treatments to maintain reduced levels of male hormones (hormone therapy). The medicine should also not be used in patients who have no symptoms, in line with the current indication; in addition, the use of Xofigo is not recommended in patients with a low number of bone metastases called osteoblastic bone metastases4.

  1. Withdrawals of applications

Raligize (axalimogene filolisbac) - The application for an initial marketing authorisation for Raligize (axalimogene filolisbac) was withdrawn. This medicine was intended to be used for the treatment of cervical cancer.

Opdivo (nivolumab) - Application to extend the use of Opdivo (nivolumab) to the treatment of stomach cancer has been withdrawn.

Sutent (sunitinib) - Application to extend the use of Sutent (sunitinib) to treat patients at high risk of kidney cancer returning after surgery has also been withdrawn.

Note - The CHMP's assessments are based on a comprehensive scientific evaluation of data. They determine whether the medicine meets the necessary quality, safety and efficacy requirements and whether it has a positive risk-benefit balance. The CHMP carries out a scientific assessment of the application and gives a recommendation on whether the medicine should be marketed or not. Once granted by the European Commission, the centralised marketing authorisation is valid in all EU Member States as well as in the countries in European Economic Area namely Iceland, Liechtenstein and Norway.

Footnotes

1 http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/07/news_detail_002994.jsp&mid=WC0b01ac058004d5c1

2 http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/07/news_detail_002997.jsp&mid=WC0b01ac058004d5c1

3 http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/07/news_detail_002998.jsp&mid=WC0b01ac058004d5c1

4 http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/07/news_detail_002996.jsp&mid=WC0b01ac058004d5c1

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Sign Up
Gain free access to lawyers expertise from more than 250 countries.
 
Email Address
Company Name
Password
Confirm Password
Position
Industry
Mondaq Newsalert
Select Topics
Select Regions
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions