EMA Committee Recommends Six Drugs for Approval at October Meeting

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval following its recent meeting, including products to treat intolerance to sunlight, ovarian cancer, oestrogen deficiency and hemophilia B. The products are:

• Clinuvel Pharmaceuticals’ Scenesse (afemelanotide) to treat patients with a rare genetic intolerance to sunlight called erythropoietic protoporphyria by stimulating production of a protein called eumelanin that protects the skin from toxic reactions caused by sunlight. CHMP also recommended that Clinuvel initiate a risk management plan with a patient registry to ensure close surveillance of EPP patients on the drug.
• AstraZeneca’s Lynparza (olaparib) as a maintenance treatment for adult women with relapsed, platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer with BRCA 1 or 2 mutations who have responded to platinum-based chemotherapy. The drug is the first of its class, promoting tumor cell death by blocking proteins that repair damaged DNA. In clinical trials, it provided 11.2 extra months of progression-free survival as compared with 4.3 months in patients on placebo.
• Pfizer’s Duavive for oestrogen deficiency in women who have been in menopause for at least a year and who still have a uterus, but cannot tolerate progestin therapy. The conjugated oestrogens in Duavive are meant to stimulate endometrial growth, while the bazedoxifene reduces the risk of hyperplasia or cancer, CHMP says.
• Baxter’s Rixubis (nonacog gamma) powder and solvent for injection to treat hemophilia B. The committee was convinced that Rixubis was beneficial in preventing and treating bleeding both during surgery and other times, CHMP says.
• Astellas Pharma’s Xtandi (enzalutamide) for an expanded indication for adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and for whom chemotherapy is contraindicated. The drug previously was approved in the EU for patients who had failed at docetaxel-based chemotherapy.
• Ariad Pharmaceuticals’ Iclusig (ponatinib) for extra warnings. Postmarket data showed a higher incidence of blood clots and blockages in arteries and veins than had been seen prior to issuing marketing approval. Iclusig is indicated in the EU for patients with chronic myeloid leukemia and acute lymphoblastic leukemia who cannot tolerate several other tyrosine-kinase inhibitors.

View the summaries of CHMP’s opinions for Scenesse, Duavive, Lymparza, Rixubis and Xtandi at www.fdanews.com/10-24-14-CHMPrecs.pdf. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.