Eight new medicines have been recommended for approval by the European Medicines Agency with three new cancer biologics also gaining the nod.
The CHMP has given authorisation for Amgen’s 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 hypercholesterolemia, a rare inherited disorder.
Three immunotherapies for the treatment of different types of cancer were granted a positive opinion by the CHMP.
They include MSD’s Keytruda (pembrolizumab) to treat advanced (unresectable or metastatic) melanoma and Bristol-Myers Squibb’s Opdivo (nivolumab) for squamous non-small cell lung cancer (NSCLC).
United Therapeutics’ Unituxin (dinutiximab) also gained the nod for treatment of high-risk neuroblastoma – a type of cancer that most often occurs in young children. Unituxin was granted an orphan designation in 2011.
The CHMP has also recommended BMS’s Evotaz (atazanavir/cobicistat) intended for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir.
Omeros’ 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.