Eight new drugs, including three cancer immunotherapies, recommended for approval by EMA/CHMP

The Committee has recommended granting a marketing authorization for US biotech major 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. 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.

Three immunotherapies for the treatment of different types of cancer were granted a positive opinion by the CHMP: Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab) to treat advanced (unresectable or metastatic) melanoma, Bristol-Myers Squibb’s (NYSE: BMY) Nivolumab BMS (nivolumab) to treat adults with squamous non-small cell lung cancer (NSCLC) and United Therapeutics’ (Nasdaq: UTHR) 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.