Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2016

Nine medicines recommended for approval, including three biosimilars

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval at its November meeting.

The CHMP recommended granting a marketing authorisation for Afstyla (lonoctocog alfa) for the prevention and treatment of bleeding in patients with haemophilia A.

Vemlidy (tenofovir alafenamide) received a positive opinion from the CHMP for the treatment of chronic hepatitis B.

Fiasp (insulin aspart) was recommended for approval by the CHMP for the treatment of diabetes.

Suliqua (insulin glargine / lixisenatide) was recommended for approval for the treatment of type 2 diabetes.

Three biosimilar medicines were recommended for approval by the Committee: Lusduna (insulin glargine) for the treatment of diabetes, and Movymia and Terrosa (both containing teriparatide) for the treatment of osteoporosis. A biosimilar medicine is a biological medicine that is similar to another biological medicine that is already authorised for use.

Two generic medicines were recommended for approval: Darunavir Mylan (darunavir) for the treatment of human immunodeficiency virus (HIV-1) infection and Tadalafil Generics (tadalafil) for the treatment of pulmonary arterial hypertension.

Five recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Arzerra, Caprelsa, Humira, Nimenrix and Vimpat.

Translarna: renewal of conditional marketing authorisation

The CHMP completed its scientific assessment of the annual renewal of the conditional marketing authorisation for Translarna (ataluren) and recommended that the conditional marketing authorisation be renewed.

As part of the CHMP assessment, the Committee reviewed all available data, including the results of a study performed by the marketing authorisation holder as a requirement of the conditional marketing authorisation after initial approval. Although the data available to date continue to indicate that Translarna slows the progression of the disease and there are no major safety concerns, the Committee considered that further comprehensive data are still needed to fully confirm that the benefit-risk balance of the medicine is positive.

The CHMP has therefore requested that the marketing authorisation holder for Translarna conducts a new 18-month randomised, placebo-controlled study in patients with Duchenne muscular dystrophy, followed by an 18-month period where all patients will be switched to Translarna. The study results are expected to be available in the first quarter of 2021.

Translarna is used to treat patients aged five years and older with Duchenne muscular dystrophy, a serious and rare condition for which no authorised treatments are currently available. The medicine is intended for use in patients who are able to walk and whose disease is caused by a specific genetic defect (called a 'nonsense mutation') in the gene for the muscle protein dystrophin.

Conditional approval allows EMA to recommend a medicine for marketing authorisation where the benefit to public health of its immediate availability on the market outweighs the risk inherent in the fact that additional data are still required. These medicines are subject to specific post-authorisation obligations that aim to generate comprehensive data on the medicine. Conditional marketing authorisations are valid for one year and can be renewed or converted to a standard five-year marketing authorisation when the additional data generated confirm that the benefit-risk balance of the medicine is positive.

The assessment report on the renewal of the conditional marketing authorisation for Translarna will be published after the European Commission issues its decision on the renewal.

Agenda and minutes

The agenda of the November 2016 CHMP meeting is published on EMA's website. Minutes of the October 2016 CHMP meeting will be published next week.

CHMP statistics

Key figures from the November 2016 CHMP meeting are represented in the graphic below.

More information on this, and all other outcomes of the CHMP's November 2016 meeting, is available in the grid below.

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Positive recommendations on new medicines

Name of medicine	Afstyla
International non-proprietary name (INN)	lonoctocog alfa
Marketing-authorisation applicant	CSL Behring GmbH
Therapeutic indication	Treatment and prophylaxis of bleeding in patients with haemophilia A
More information	Summary of opinion for Afstyla

Name of medicine	Fiasp
International non-proprietary name (INN)	insulin aspart
Marketing-authorisation applicant	Novo Nordisk A/S
Therapeutic indication	Treatment of diabetes
More information	Summary of opinion for Fiasp

Name of medicine	Suliqua
International non-proprietary name (INN)	insulin glargine / lixisenatide
Marketing-authorisation applicant	Sanofi-aventis groupe
Therapeutic indication	Treatment of type 2 diabetes
More information	Summary of opinion for Suliqua

Name of medicine	Vemlidy
INN	tenofovir alafenamide
Marketing-authorisation applicant	Gilead Sciences International Ltd
Therapeutic indication	Treatment of chronic hepatitis B
More information	Summary of opinion for Vemlidy

Positive recommendations on new generic medicines

Name of medicine	Darunavir Mylan
INN	darunavir
Marketing-authorisation applicant	MYLAN S.A.S
Therapeutic indication	Treatment of human immunodeficiency virus (HIV-1) infection
More information	Summary of opinion for Darunavir Mylan

Name of medicine	Tadalafil Generics
INN	tadalafil
Marketing-authorisation applicant	MYLAN S.A.S
Therapeutic indication	Treatment of pulmonary arterial hypertension
More information	Summary of opinion for Tadalafil Generics

Positive recommendations on new biosimilar medicines

Name of medicine	Movymia
INN	teriparatide
Marketing-authorisation applicant	STADA Arzneimittel AG
Therapeutic indication	Treatment of osteoporosis
More information	Summary of opinion for Movymia

Name of medicine	Terrosa
INN	teriparatide
Marketing-authorisation applicant	Gedeon Richter Plc.
Therapeutic indication	Treatment of osteoporosis
More information	Summary of opinion for Terrosa

Positive recommendations on extensions of therapeutic indications

Name of medicine	Caprelsa
INN	vandetanib
Marketing-authorisation holder	Genzyme Europe BV
More information	Summary of opinion for Caprelsa

Name of medicine	Humira
INN	adalimumab
Marketing-authorisation holder	AbbVie Ltd
More information	Summary of opinion for Humira

Name of medicine	Nimenrix
INN	meningococcal group A, C, W135 and Y conjugate vaccine
Marketing-authorisation holder	Pfizer Limited
More information	Summary of opinion for Nimenrix

Name of medicine	Vimpat
INN	lacosamide
Marketing-authorisation holder	UCB Pharma S.A.
More information	Summary of opinion for Vimpat

Other opinion

Name of medicine	Ruconest
INN	conestat alfa
Marketing-authorisation holder	Pharming Group N.V
More information	Summary of opinion for Ruconest

Other updates

Recommendations on eligibility to PRIME scheme

Scientific advice and protocol assistance

Start of community reviews

Overview of (invented) names reviewed in October 2016 by the Name Review Group (NRG)