Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2016
News
Human
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.
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 | CHMP summary of positive 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 | CHMP summary of positive 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 | CHMP summary of positive 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 | CHMP summary of positive 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 | CHMP summary of positive 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 | CHMP summary of positive opinion for Tadalafil Generics |
Positive recommendations on new biosimilar medicines
| Name of medicine | Lusduna |
|---|---|
| INN | insulin glargine |
| Marketing-authorisation applicant | Merck Sharp & Dohme Limited |
| Therapeutic indication | Treatment of diabetes |
| More information |
| Name of medicine | Movymia |
|---|---|
| INN | teriparatide |
| Marketing-authorisation applicant | STADA Arzneimittel AG |
| Therapeutic indication | Treatment of osteoporosis |
| More information | CHMP summary of positive opinion for Movymia |
| Name of medicine | Terrosa |
|---|---|
| INN | teriparatide |
| Marketing-authorisation applicant | Gedeon Richter Plc. |
| Therapeutic indication | Treatment of osteoporosis |
| More information | CHMP summary of positive opinion for Terrosa |
Positive recommendations on extensions of therapeutic indications
| Name of medicine | Arzerra |
|---|---|
| INN | ofatumumab |
| Marketing-authorisation holder | Novartis Europharm Ltd |
| More information |
| Name of medicine | Caprelsa |
|---|---|
| INN | vandetanib |
| Marketing-authorisation holder | Genzyme Europe BV |
| More information | CHMP post-authorisation summary of positive opinion for Caprelsa |
| Name of medicine | Humira |
|---|---|
| INN | adalimumab |
| Marketing-authorisation holder | AbbVie Ltd |
| More information | CHMP post-authorisation summary of positive opinion for Humira |
| Name of medicine | Nimenrix |
|---|---|
| INN | meningococcal group A, C, W135 and Y conjugate vaccine |
| Marketing-authorisation holder | Pfizer Limited |
| More information | CHMP post-authorisation summary of positive opinion for Nimenrix |
| Name of medicine | Vimpat |
|---|---|
| INN | lacosamide |
| Marketing-authorisation holder | UCB Pharma S.A. |
| More information | CHMP post-authorisation summary of positive opinion for Vimpat |
Other opinion
| Name of medicine | Ruconest |
|---|---|
| INN | conestat alfa |
| Marketing-authorisation holder | Pharming Group N.V |
| More information | CHMP post-authorisation summary of positive opinion for Ruconest |
Other updates
| Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 7-10 November 2016 |
| Scientific advice and protocol assistance adopted during the CHMP meeting 7 – 11 November 2016 |
| Start of community reviews - CHMP meeting of 07-10 November 2016 |
| Overview of (invented) names reviewed in October 2016 by the Name Review Group (NRG) |