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


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


Ilumetri (tildrakizumab)

Treatment of moderate to severe plaque psoriasis

Almirall S.A.


Imfinzi (durvalumab)

Treatment of non-small cell lung cancer

AstraZeneca AB


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


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.


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.


Symkevi (tezacaftor / ivacaftor)

Treatment of cystic fibrosis

Vertex Pharmaceuticals (Europe) Ltd.


Verzenios (abemaciclib)

Treatment of locally advanced or metastatic breast cancer

Eli Lilly Nederland B.V.


Xerava (eravacycline)

Treatment of complicated intra-abdominal infections in adults

Tetraphase Pharmaceuticals Ireland Limited


Deferiprone Lipomed (deferiprone)

Treatment of iron overload in patients with thalassemia major

Lipomed GmbH


Gefitinib Mylan (gefitinib)

Treatment of non-small cell lung cancer

Mylan S.A.S.


Lenalidomide Accord (lenalidomide)

Treatment of multiple myeloma

Accord Healthcare Limited


Hulio (adalimumab)

Treatment of certain inflammatory and autoimmune disorders

Mylan S.A.S


Pelgraz (pegfilgrastim)

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

Accord Healthcare Limited


Udenyca (pegfilgrastim)

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

ERA Consulting GmbH


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.






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