Just days after rejecting Arena's obesity drug lorcaserin, the FDA has issued a complete response letter for Vivus' Qnexa, one of three closely-watched obesity drugs up for approval. Previously, an expert panel voted 10 to 6 against approval of the drug, with many panel members seeking more safety data for Qnexa.
The CRL included the following areas, according to the Vivus (NASDAQ: VVUS) release: clinical, labeling, REMS, safety update and drug scheduling. Specifically, the FDA wants a detailed plan to handle the risks Qnexa may present to women who are pregnant or may become pregnant. The agency also want data proving that elevated heart rate associated with the drug doesn't lead to cardiovascular problems. Vivus will have to provide results from an already completed 52-week study of the drug, an extension study for a subset of 675 patients who completed the CONQUER study. FDA requested continued discussion of Vivus' already-submitted REMS plan. Finally, the agency asked for safety update of any new adverse. Like lorcaserin, Qnexa will be a Schedule IV drug due to the phentermine component.
The good news here is that the agency didn't ask for any new trials of the drug. However, if Vivus is unable to address the issues presented in the CRL, the FDA may require a new Qnexa trial. In a conference call, CEO Tim Morris noted that the CRL did not address any questions about Qnexa's efficacy. He added that the company doesn't plan on requesting a type A meeting with FDA before resubmission.
"We remain confident in the efficacy and safety profile of QNEXA demonstrated in the clinical development program and look forward to continue working with the FDA towards the approval for the treatment of obesity," said Vivus CEO Leland Wilson. "We are preparing a comprehensive response to the CRL for submission to the FDA in approximately six weeks." Vivus has $155 million on hand at the end of September, enough, it says, to see the company through Qnexa's approval.
- read the Vivus release for more