Eight new medicines, including three cancer immunotherapies, recommended for approval

Eight new medicines have been recommended for approval at the May 2015 meeting of the Committee for Medicinal Products for Human Use (CHMP).

The Committee has recommended granting a marketing authorisation for Repatha (evolocumab), a first-in-class treatment to lower high levels of cholesterol in the blood of people who are unable to control their cholesterol despite taking optimal doses of statins or who cannot take statins. Repatha is also recommended to treat homozygous familial hypercholesterolaemia, a rare inherited disorder. Repatha is the first monoclonal antibody in this therapeutic area and provides a new treatment option for patients who are unable to control their high cholesterol despite taking currently available therapies. For more information on Repatha, please see the press release in the grid below.

Three immunotherapies for the treatment of different types of cancer were granted a positive opinion by the CHMPKeytruda (pembrolizumab) to treat advanced (unresectable or metastatic) melanoma, Nivolumab BMS (nivolumab) to treat adults with squamous non-small cell lung cancer (NSCLC) and Unituxin (dinutiximab) for the treatment of high-risk neuroblastoma – a type of cancer that most often occurs in young children. Unituxin was granted an orphan designation in 2011. Cancer immunotherapies are treatments that use the body’s own immune system to fight the disease. For more information on these cancer medicines, please see the press releases in the grid below.

The CHMP recommended Evotaz (atazanavir / cobicistat) intended for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir.

Omidria (phenylephrine / ketorolac) received a positive opinion from the Committee for maintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery.

Two generic medicines received positive opinions from the CHMPBortezomib Accord (bortezomib) for the treatment of multiple myeloma and mantle cell lymphoma and Pregabalin Zentiva (pregabalin) for the treatment of epilepsy and generalised anxiety disorder.

Six recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Fycompa, Imbruvica,KuvanSimponi, Stelara and Xultophy. For more information on the extension ofindication for Imbruvica, please see the press release in the grid below.

Outcome of re-examination of GVK Bio Sciences

The CHMP has confirmed its recommendation to suspend a number of medicines for which authorisation in the European Union were primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India. This is the outcome of a re-examination requested by marketing authorisation holders for seven of the medicines concerned.


Posted on the EMA website on 22 May 2015