European Union: European Medicines Agency (EMA): Recommends Approval Of Thirteen Medicines In Its September Meeting

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended thirteen medicines for approval, including three orphan medicines, at its September 2018 meeting1. The approvals include the first gene therapy Luxturna for the treatment of adults and children with a rare inherited retinal dystrophy disease, and Emgality, a new class of drug for prevention of migraine.

  1. The thirteen medicines recommended for approval are:

Sl. No.

Name of Medicine

Indicated For

Marketing-Authorisation Holder

1

Luxturna (voretigene neparvovec)

Treatment of retinal dystrophies caused by RPE65 mutations

Spark Therapeutics Ireland Ltd

2

Emgality (galcanezumab)

Prophylaxis of migraine

Eli Lilly Nederland B.V.

3

Vabomere (meropenem / vaborbactam)

Treatment of the following infections in adults:

- Complicated urinary tract infection (cUTI), including pyelonephritis

- Complicated intra-abdominal infection (cIAI)

- Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).

Rempex London Ltd

4

Jivi (damoctocog alfa pegol)

Treatment of haemophilia A (congenital factor VIII deficiency

Bayer AG

5

Poteligeo (mogamulizumab)

Treatment of mycosis fungoides or Sézary syndrome

Kyowa Kirin Limited

6

Alunbrig (brigatinib)

Treatment of adult patients with anaplastic lymphoma kinase positive advanced non-small cell lung cancer previously treated with crizotinib

Takeda Pharma A/S

7

Apealea (paclitaxel)

Treatment of ovarian cancer

Oasmia Pharmaceutical AB

8

Delstrigo (doravirine / lamivudine / tenofovir disoproxil)

Treatment of HIV-1 infection

Merck Sharp & Dohme B.V.

9

Pifeltro (doravirine)

Treatment of HIV-1 infection

Merck Sharp & Dohme B.V.

10

Fulphila (pegfilgrastim)

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

MYLAN S.A.S

11

Pelmeg (pegfilgrastim)

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

Cinfa Biotech S.L.

12

Ziextenzo (pegfilgrastim)

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

Sandoz GmbH

13

Buvidal (buprenorphine)

Treatment of opioid dependence

Camurus AB

  1. Negative recommendations on new medicines following re-examination

The CHMP has issued a negative recommendation for one drug Exondys (eteplirsen), intended for the treatment of Duchenne muscular dystrophy. The applicant company, AVI Biopharma International Ltd, had requested a re-examination of the CHMP's opinion on June 01, 2018. After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorization2.

  1. CHMP recommendations on extensions of therapeutic indication

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a change to the terms of the marketing authorisation for seven drugs on extensions of therapeutic indication as described in table (New indications are marked in bold, and deleted indications are marked in strikethrough)

Sl.no.

Name of medicine

Full Indication

Marketing-authorisation holder

1

Cabometyx (cabozantinib)

CABOMETYX is indicated for the treatment of advanced renal cell carcinoma (RCC):

- in treatment-naïve adults with intermediate or poor risk (see section 5.1)

- in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy

Hepatocellular Carcinoma (HCC)

CABOMETYX is indicated as monotherapy for the treatment of hepatocellular carcinoma

(HCC) in adults who have previously been treated with sorafenib.

Ipsen Pharma3

2

Elebrato Ellipta (fluticasone furoate / umeclidinium / vilanterol fluticasone)

Elebrato Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations)

GlaxoSmithKline Trading Services Limited4

3

Gilenya (fingolimod)

Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older:

-Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy, or

-Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

Novartis Europharm Limited5

4

RoActemra (tocilizumab)

RoActemra, in combination with methotrexate (MTX), is indicated for:

- the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.

- the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.

In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.

RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.

RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX.

RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

RoActemra is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.

Roche Registration GmbH6

5

Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol fluticasone)

Trelegy Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist.

GlaxoSmithKline Trading Services Limited7

6

Venclyxto (venetoclax)

Venclyxto in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.

Venclyxto monotherapy is indicated for the treatment of chronic lymphocytic leukaemia (CLL):

-in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or

-Venclyxto monotherapy is indicated for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemo-immunotherapy and a B-cell receptor pathway inhibitor.

AbbVie Deutschland GmbH & Co. KG8

7

Xtandi (enzalutamide)

Xtandi is indicated for:

-the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC).

-the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.

-the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.

Astellas Pharma Europe B.V.9

  1. Update on valsartan review

The European Medicines Agency (EMA) is expanding its review of impurities in valsartan following the detection of very low levels of N-nitrosodiethylamine (NDEA) in another active substance, losartan, made by Hetero Labs in India. As a result of the detection of this impurity by German authorities, the review will now include medicines containing four other 'sartans', namely, candesartan, irbesartan, losartan and olmesartan. These active substances have a specific ring structure (tetrazole) whose synthesis could potentially lead to the formation of impurities such as NDEA. Other medicines of the class which do not have this ring are not included in the review10.

  1. Withdrawals of applications

Applications for initial marketing authorisations for Entolimod TMC (entolimod) and Treprostinil SciPharm Sàrl (treprostinil) have been withdrawn. Treprostinil SciPharm Sàrl was intended to be used to treat chronic thromboembolic pulmonary hypertension.

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 that it has a positive risk-benefit balance. The CHMP carry out a scientific assessment of the application and give 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 European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.

Footnotes

1 http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/09/news_detail_003019.jsp&mid=WC0b01ac058004d5c1

2 http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004355/WC500249920.pdf

3 http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/004163/WC500255711.pdf

4 http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/004781/WC500255740.pdf

5 http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/002202/WC500255699.pdf

6 http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/000955/WC500255613.pdf

7 http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/004363/WC500255741.pdf

8 http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/004106/WC500255701.pdf

9 http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/002639/WC500255611.pdf

10 http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/09/news_detail_003023.jsp&mid=WC0b01ac058004d5c1

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