Drug approvals for Bayer in USA and Japan

There were two pieces of good news for German Pharma and chemicals major Bayer (BAYN: DE) on Friday (November 22), first Japanese clearance for its ophthalmic drug Eylea (aflibercept) and, later in the day, a new indication in the USA for cancer drug Nexavar (sorafenib).

The US Food and Drug Administration expanded the approved uses of Nexavar, which is co-marketed with USA-based Onyx Pharmaceuticals, which is now a subsidiary of leading biotech firm Amgen (Nasdaq: AMGN) following a recently concluded $10.4 billion takeover bid, to treat late-stage (metastatic) differentiated thyroid cancer.

The FDA completed its review of Nexavar’s new indication under its priority review program, which provides for an expedited, six-month review for drugs that may offer a significant improvement in safety or effectiveness of the treatment, prevention or diagnosis of a serious condition. Nexavar also received orphan-product designation by the FDA because it is intended to treat a rare disease or condition.

The FDA approved Nexavar to treat advanced kidney cancer in 2005. In 2007, the agency expanded the drug’s label to treat liver cancer that cannot be surgically removed. In its current indications, Nexavar is already generating annual sales in excess of $1 billion.