Allergan Inc. (AGN), the maker of the Botox wrinkle treatment, failed to win U.S. approval for its inhalable version of a 60-year-old migraine drug after regulators raised concerns about manufacturing.
The Food and Drug Administration rejected Allergan’s Levadex, an inhaled form of dihydroergotamine, as an acute treatment for patients suffering from migraine attacks, the Irvine, California-based company said today in a statement. If approved, the use of Levadex would not be limited by the monthly number of migraines suffered by a patient as Botox is, Heather Katt, an Allergan spokeswoman, said in an e-mail.
Allergan said it completed the purchase of canister-filling maker Exemplar Pharma LLC last week to help address the FDA concerns about that section of the supply chain and expects a re-inspection of Exemplar will be required before approval can be won. The FDA also has concerns about the manufacturing process of the final-filled canisters.
The FDA’s decision “is disappointing but resolvable in our view,” Seamus Fernandez, an analyst with Leerink Swann & Co., said in a note to clients. “Manufacturing and decision making is now 100 percent under Allergan’s control. Allergan’s excellent track record on manufacturing and FDA relations deserves and appears to be getting full credit.”
More than 36 million Americans suffer from migraines, a collection of neurological symptoms that can include searing headaches, dizziness, nausea and as sensitivity to sound and light. Dihydroergotamine works by narrowing blood vessels in the brain that swell during a migraine. The present form of the drug, approved by the FDA in 1946, has been shown to be effective as an injection against severe pain.
Levadex was developed by Map Pharmaceuticals Inc. (MAPP), which was acquired by Allergan earlier this year in a deal valued at $958 million. The FDA rejected the therapy a year ago after regulators questioned the manufacturing process.
Botox is approved as a treatment for chronic migraine patients, those who suffer attacks more than 15 days a month.
Allergan fell less than 1 percent to $113.12 at the close of trading in New York. The stock has gained 23 percent this year.
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