CHMP backs Invokana, Xofigo, Abilify Maintena
EMA's CHMP recommended approval of a number of products, including Invokana canagliflozin from Johnson & Johnson (NYSE:JNJ) to treat Type II diabetes as monotherapy or as add-on therapy in adults. FDA approved the sodium-glucose cotransporter 2 (SGLT2) inhibitor to treat Type II diabetes in March. J&J has worldwide rights to the product except in some parts of Asia from Mitsubishi Tanabe Pharma Corp. (Tokyo:4508; Osaka:4508).
The committee also recommended approval of Xofigo radium-223 dichloride from Bayer AG (Xetra:BAYN) to treat adults with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastases. Bayer has rights to the radiopharmaceutical based on the alpha particle emitter radium-223 from Algeta ASA (OSE:ALGETA) under a 2009 deal. Xofigo is approved for the indication in the U.S., where the companies co-promote it. On Friday, Algeta was up NOK3.40 to NOK244.40. ...