Eleven new medicines, including one orphan, recommended for approval
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.
Posted on the EMA website on 24 April 2015