|VIVUS Announces FDA Approval of Qsymia REMS; Allergan Receives Complete Response Letter from the FDA for LEVADEX|
|By Staff and Wire Reports|
|Tuesday, 16 April 2013 18:53|
VIVUS (Nasdaq: VVUS) announced that the U.S. FDA has approved its amendment and modification to the Risk Evaluation and Mitigation Strategy (REMS) for Qsymia® (phentermine and topiramate extended-release) capsules CIV. The amendment, submitted in October 2012, allows Qsymia to be dispensed through certified retail pharmacies, in addition to the existing network of certified mail-order pharmacies.
"With FDA approval of the REMS modification, today we begin the process of increasing the availability of Qsymia, simplifying prescribing and dispensing and resolving the challenges associated with the mail-order-only system," said Peter Tam, president of VIVUS. "Our goal over the next three months is to ensure availability of Qsymia in thousands of certified retail pharmacies nationwide. The REMS modification is a key accomplishment in removing a major barrier that has hindered the initial acceptance of Qsymia into everyday medical practice. We believe that retail access, along with ongoing improvements in reimbursement, will help to accelerate Qsymia awareness, trial and usage."
"The addition of certified retail pharmacies to the Qsymia network will reduce the prescribing burden for physicians and the waiting times for patients seeking to initiate therapy for obesity," said Barbara Troupin, MD, vice president, scientific communication and risk management, VIVUS. "While the Qsymia certified mail-order pharmacies will remain, the addition of retail availability will improve the overall physician and patient experience."
With this modification, the goals, commitments and components of the original Qsymia REMS will remain in place, including a Medication Guide, patient brochure, voluntary healthcare provider training and other educational tools. These will continue to be available as part of the modified Qsymia REMS program. Availability at certified retail pharmacies is expected within 90 days. Until further notice, healthcare providers and patients should continue to utilize the current certified mail-order network.
Allergan, Inc. (NYSE: AGN) announced the U.S. 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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VIVUS, Inc. (Nasdaq: VVUS) today announced that the U.S. Food and Drug Administration (FDA) has approved its amendment and modification to the Risk Evaluation and Mitigation Strategy (REMS) for Qsymia®(phentermine and topiramate extended-release) capsules CIV.