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Eleven new medicines, including one orphan, recommended for approval

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2015

London (April 24, 2015) – Eleven new medicines were recommended for approval at the April 2015 meeting of the Committee for Medicinal Products for Human Use (CHMP).
The CHMP recommended granting a marketing authorisation for Opdivo (nivolumab), for the treatment of adults with advanced (unresectable or metastatic) melanoma. For more information on Opdivo, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Hetlioz (tasimelteon) to treat non-24-hour sleep-wake disorder in totally blind adults. Hetlioz was granted orphan designation in 2011. For more information on Hetlioz, please see the press release in the grid below.

Lixiana (edoxaban) received a positive opinion from the Committee for the prevention of stroke and systemic embolism in atrial fibrillation, and the prevention and treatment of venous thromboembolism.

LuMark (Lutetium (177Lu) chloride), a radiopharmaceutical precursor, received a position opinion from the CHMP for the radiolabelling of carrier molecules.

The following seven generic medicines received a positive opinion from the CHMP: Aripiprazole Pharmathen (aripiprazole) for the treatment of schizophrenia and treatment and prevention of manic episodes of bipolar 1 disorder; Aripiprazole Zentiva (aripiprazole) for the treatment of schizophrenia and treatment and prevention of manic episodes in bipolar 1 disorder; Duloxetine Mylan (duloxetine) for the treatment of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder; Pregabalin Mylan (pregabalin) for the treatment of epilepsy and generalised anxiety disorder; Pregabalin Mylan Pharma (pregabalin) for the treatment of neuropathic pain, epilepsy and generalised anxiety disorder; Pregabalin Sandoz (pregabalin) for the treatment of epilepsy, neuropathic pain and generalised anxiety disorder and Pregabalin Sandoz GmbH for the treatment of epilepsy and generalised anxiety disorder.

Negative opinion on new medicine

The CHMP adopted a negative opinion for Lympreva (dasiprotimut-T) which was intended for the treatment of patients with follicular non-Hodgkin’s lymphoma.

Six recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Esmya, Invega, Levemir, Relistor, Resolor and Tygacil.

CHMP recommends avoiding use of certain hepatitis C medicines with amiodarone

The CHMP confirmed a risk of severe bradycardia or heart block when the hepatitis C medicines Harvoni (sofosbuvir with ledipasvir) or a combination of Sovaldi (sofosbuvir) and Daklinza (daclatasvir) are used in patients who are also taking the antiarrhythmic amiodarone. To manage this risk, the CHMP recommends that in patients taking these medicines, amiodarone should only be used if other antiarrhythmics cannot be given. For more information, please see the public health communication in the grid below.

Withdrawal of application

The application for marketing authorisation for Duloxetine Sandoz (duloxetine) has been withdrawn.

A question-and-answer document on this withdrawal is available in the grid below.

Agenda and minutes

The agenda of the April 2015 meeting is published on EMA’s website. The minutes of the meeting will be published during the week following the May CHMP meeting.

CHMP statistics

Key figures from the April 2015 CHMP meeting are represented in the graphic below.

More information on this, and all other outcomes of the CHMP’s April 2015 meeting, is available in the grid below.

Positive recommendations on new medicines

Negative recommendation on new medicine   

Positive recommendations on new generic medicines

Positive recommendation on new therapeutic indications

Public health recommendation

Outcome of arbitration procedure

Withdrawal of application 

Other updates

European Medicines Agency, 24.04.2015 (tB).