In a decision that is not very surprising, an FDA advisory committee voted 9-to-5 that the risks of the Lorqess diet drug developed by Arena Pharmaceuticals outweigh the benefits. The move came after concerns about valvulopathy and links to malignancies in rats at higher doses, which were revealed unexpectedly in FDA briefing documents (see here).
This is the second time in recent weeks that the FDA Endocrinologic and Metabolic Advisory committee has shot down a new diet drug. In July, the panel Qnexa pill developed by Vivus (see this). The vote also is a big setback for Eisai, which recently paid $50 million for the rights to sell Arena's drug; and agreed to cough up $160 million based on development and approval milestones, and a $1.16 billion, one-time payment based on annual sales. Instead, pfft... More recently,Takeda Pharmaceuticals agreed to pay Orexigen Therapeutics $50 million for exclusive North American marketing rights (but co-promotion in the US) for its Contrave pill, which the panel will review in a few months.
Arena is holding a conference call and webcast now to discuss the vote (look here).
2 Comments
In my shop the basic formula has always been:
RATS GET CANCER = KILL THE DRUG.
Unfortunately, the head of Pharm/Tox in many companies is not really a "Power" position, and can easily get overruled by those in other departments who will green light clinical development to meet their own agendas, rather than act in the interest of patient safety. Same deal even when safety signals pop up in Phase I. The prevailing attitude is that of "kicking the can down the road", meaning that "we'll figure out a way to smooth out the rough spots when we get closer to the NDA". By that time, the Pharm/Tox head has probably moved on, and some poor shnook in Corporate Regulatory Affairs is left to pick up the pieces and face the firing squad both from inside the company and from the FDA.
Nasty, but true.
Looks like you're in for a rude awakening soon.