Arena’s June 27th PDUFA date is quickly approaching. After the FDA Advisory Committee voted strongly in favor of approving Lorcaserin, for the treatment of obesity, mostly all pundits and analyst have all but claimed victory for Arena’s upcoming PDUFA date. We feel that despite modest efficacy, Lorcaserin has a high degree of likelihood for approval. […]
ARNA, VVUS & OREX – Update after Lorcaserin AdCOM
Yesterday, the FDA Advisory Committee voted strongly in favor of approving Lorcaserin, for the treatment of obesity. Previously, our group felt that ARNA’s Lorcaserin along with OREX’s Contrave would eventually gain regulatory approval, but that there would be some delay. In the case of ARNA, we were impressed at how eager the Advisory Committee was […]
ARNA – Quick take on FDA Adcom
Our coverage of the anti-obesity sector continues. Yesterday, the FDA released the briefing documents regarding Arena’s application for Lorcaserin. Lorcaserin, or Lorqess, is a novel therapeutic candidate for treatment of obesity. Brief History: In 2010, Arena submitted the NDA for Lorcaserin, a subsequent AdCom voted against the application, five on the roster voted for the […]
VVUS, OREX, ARNA – Understanding the Advisory Committee
Playing VVUS, OREX, ARNA through FDA Adcomm and Qnexa PDUFA Over the past several months, these three companies, with their respective late-stage anti-obesity drug candidates, have experienced a considerable increase in volatility and share price, due in part to new regulatory revelations regarding clinical pathways to regulatory approval. We believe there will continued volatility leading […]
Vivus Investors Flee to Arena Pharmaceuticals
Jason Chew Vivus shares tanked after an expert panel voted 10 to 6 against approving its obesity drug, Qnexa. The panel was particularly worried that Vivus only had one year data for its drug- not long enough in its opinion to gather long term safey data in light of Qnexa’s CNS and Cardiovascular side effects. Qnexa […]
Why Arena’s Lorcaserin Will Not Be Used In Combination With Phentermine
Jason Chew It is tempting to believe that once Lorcaserin has been approved, it will be used off-label in combination with phentermine to create a safe and efficacious version of Fen-Phen, the once popular diet drug. This is not to be the case. Some history:Fenfluramine, the “Fen” in Fen-Phen, a potent agonist of 5-HT2B receptors, […]
