Arena Pharmaceuticals ($ARNA) has decided to take its drug application and go home. The drugmaker Friday said it was giving up for now on breaking through the European wall of resistance to its weight-loss drug Belviq. The company, which got FDA approval last year, yanked its application with little explanation.
Regulators in Europe in January told the company there was a long list of concerns, and Arena decided it couldn't check them all off before the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) made a final ruling, according to Reuters. It is not as if CHMP is just picking on Belviq, a drug that some analysts believe might hit $1 billion in sales once it gets into the market. The CHMP gave the same kind of cold shoulder to competitor Vivus' ($VVUS) weight-loss drug Qsymia in February. In that case it turned Vivus' drug down for the second time.
Qsymia and Belviq are the first weight-loss drugs to get through the FDA in more than a decade. U.S. regulators raised concerns about both, but as obesity has become a huge concern, decided to approve them. Qsymia has made a rather tepid debut in the U.S., but Belviq requires a decision by the Drug Enforcement Agency to determine if its potential for drug abuse should require restrictions. That process was expected to take four to 6 months, but it has been more than 10. The Financial Times says that there have been a significant number of comments filed that the DEA has been sifting through. While those people supporting approval signed their names to their comments, 19 of the 22 objections were anonymous. That has stirred some supporters to believe they were made by parties with vested financial interest, like short sellers.
That delay is allowing Vivus to get some traction in the market ahead of the Belviq launch. Qsymia got a big boost last month when the FDA agreed to lift a provision restricting sales to mail-order pharmacies, paving the way to getting the obesity drug into thousands of retail pharmacy outlets around the country. "The FDA enabling us to go out to retail pharmacies is a huge win," CEO Peter Tam told The Wall Street Journal at the time. "It's like a Formula One race car--we know we can go really fast, but we've been held in the pit lane."
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