Allergan Gets FDA Approval for Orzurdex, Rejection for Levadex

Allergan Inc., the drugmaker resisting a takeover by Valeant Pharmaceuticals International Inc., won U.S. approval for a treatment of vision loss in diabetics and rejection for its migraine inhaler.

The Food and Drug Administration approved Allergan’s Ozurdex, a drug for diabetic macular edema, which can cause vision loss and eventual blindness in people with diabetes, according to a regulatory filing today. The agency rejected Semprana, formerly known as Levadex, an inhalable treatment for migraines, because of problems with the drug’s delivery device.

An eventual approval for Levadex could “vindicate” Allergan’s research capabilities and its argument to investors that it’s better off alone than as part of Valeant, according to Shibani Malhotra, an analyst at Sterne Agee & Leach Inc. wrote in a June 23 note to clients. Allergan plans to meet with the FDA about Semprana and estimates the agency could have an answer on the drug by July 2015, according to the filing.

Allergan, based in Irvine, California, is resisting a $54 billion takeover offer by Valeant, which has twice raised its bid as it seeks to become one of the world’s five biggest drugmakers. Valeant has teamed with Bill Ackman, whose hedge fund Pershing Square Capital Management LP took a 9.7 percent stake in Allergan to drive the deal.

The company said its experimental treatment for wet age-related macular degeneration, a disease that causes vision loss, will start the last of three stages of clinical trials typically required for FDA approval. A glaucoma treatment will also move into phase 3 trials by the end of this year, the company said.

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