Allergan Receives Complete Response Letter from the FDA for LEVADEX
Allergan, Inc. (NYSE: AGN) today announced that the U.S. Food and Drug
Administration (FDA) has issued a Complete Response Letter (CRL) to its New
Drug Application (NDA) for LEVADEX(R) (dihydroergotamine) inhalation aerosol
for the acute treatment of migraine in adults.
Allergan is pleased that, in addition to the response, the company has
already received draft labeling from the FDA. Allergan anticipates minimal
revisions to this labeling. The company is committed to bringing LEVADEX(R)
to market as a potential new acute treatment to address a significant unmet
need among the millions of people living with debilitating migraines.
The main issues cited in the CRL were already identified by the FDA in prior
discussions with Allergan. The company has already taken the following
actions to address these concerns:
1. Per the FDA's comments in the CRL, during a previous inspection, the
agency noted concerns with Exemplar Pharma, LLC, the canister filling
unit manufacturer. In accordance with Allergan's overall manufacturing
strategy to secure our supply chain, Allergan completed the acquisition
of Exemplar on April 12th, 2013, for less than $20 million. Allergan has
appointed senior members of Allergan's Global Technical Operations to
oversee the facility. Allergan anticipates that the FDA will require a
re-inspection of the Exemplar facility prior to approval.
2. The FDA also noted concerns regarding the manufacturing process for the
final filled canisters. Allergan has already responded to this concern.
As the FDA indicated in the CRL, the Agency has not yet reviewed
Allergan's response under the current PDUFA timeline.
Allergan is committed to vigorously address the concerns raised by the FDA
in the CRL. Based on Allergan's current understanding of the FDA's CRL, the
company estimates that the next FDA action will occur by the end of Q4 2013.
In addition, based on our assessment of the above, Allergan reiterates
guidance regarding earnings per share (EPS) which was previously issued on
February 5(th) . Even with an FDA approval under the original timeline, 2013
sales of LEVADEX(R) would have been minimal. Today's FDA response will not
materially impact overall Allergan 2013 sales guidance. In the regular
course of business, Allergan will provide a full update on the company's
Quarterly Earnings call, which will take place on May 1(st) , 2013.
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