Drug firms await FDA ruling on Arixtra
BY MARK COURT, HEALTH INDUSTRIES CORRESPONDENT
THE global drugs industry is anxiously awaiting the outcome of an investigation by the US Food and Drug Administration’s into Arixtra. A decision by the FDA not to approve the drug, intended to prevent blood clots, will be seen as a key indicator of the regulator’s hardening stance on the safety of medicines.
The pharmaceutical industry has come under increasing pressure from regulators over drug safety, highlighted by last week’s withdrawal of Baycol, a cholesterol-lowering drug.
On Wednesday the FDA is expected to rule on Arixtra, a potential blockbuster developed by the French drugs group Sanofi-Synthélabo, but which has potential side-effect of internal bleeding.
Kevin Scotcher, an analyst with SG Cowen, said: “The FDA is going to look at how well it prevents deep vein thrombosis and balance that against the bleeding episodes.
“But the way the FDA puts safety and efficacy into the balance has shifted and it is perhaps looking more closely at safety.”
Analysts say it is impossible to forecast whether the FDA will approve Arixtra even though a similar drug, Lovenox developed by Aventis, a rival French group, is already on the market.
Andrew Pendrill, an analyst with ABN Amro, said: “The question mark is over the bleeding effect and the decision could go either way. If it is rejected, or if the FDA asks for further safety studies, it will help to clarify the FDA’s position on safety.”
Last week’s withdrawal of Baycol sent shockwaves through the pharmaceutical industry, which in the past year has seen an increasing number of drugs withdrawn for safety reasons, including GlaxoSmithKline’s Lotronex for irritable bowel syndrome.
Last month the FDA declined to approve Zelmac, Novartis’s drug for irritable bowel syndrome.
Investors’ money has flowed strongly into pharmaceuticals since last year because of the sector’s defensive qualities, but the attractions have been undermined by regulatory uncertainty.
SG Cowen, the broker, says: “The bottom line is that investors should continue to be cautious.”
Shares in Sanofi-Synthélabo have underperformed the sector in recent weeks because of nervousness about Arixtra. |
