Obesity Pill Manufacturers to Take Another Shot at FDA Approval for Contrave, Lorqess, Qnexa
Three companies are going to take another shot at getting FDA approval for their obesity pills.
Arena Pharmaceuticals, Orexigen Therapeutics, and Vivus Inc. have all made announcements that indicate their optimism in terms of winning FDA approval, ABC News reported.
Arena Pharmaceuticals is the manufacturer of Lorqess.
The company said earlier this year that tests have found significant decreases in obesity rates among participants who received the drug, as opposed to those who received placebos.
We are pleased to have the opportunity to share and discuss the results from the lorcaserin Phase 3 program with the European medical community at ECO, and we look forward to submitting a Marketing Authorization Application for regulatory approval of lorcaserin in Europe next year, vice president of Lorcaserin development Christen M. Anderson said in a company statement.
Orexigen is the manufacturer of Contrave.
The company spoke about a viable path forward for Contrave, the timing of and potential for success with the dispute resolution process for Contrave, and the potential for, and timing of, approval for Contrave, in a statement.
Vivus is the manufacturer of Qnexa.
The company announced on Thursday that patients who were treated over a two-year period with Qnexa had significant reductions in the progression to type-2 diabetes. They also had an improved glycemic status, the company said.
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