GlaxoSmithKline's Avandia will not be available in US pharmacies from the middle of November after the Food and Drug Administration imposed further restrictions on the controversial diabetes drug.
The agency restricted access to Avandia (rosiglitazone) in September, though it allowed the drug to remain on the market, unlike its European counterpart which suspended sales, based on data suggesting that it could put patients at an increased risk from heart disease. Now that already-limited access is being cut further.
The FDA says that patients and healthcare providers must now enroll in a special programme in order to prescribe and receive Avandia, Avandamet (rosiglitazone/metformin) and Avaglim (rosiglitazone/glimepride). The new restrictions are part of an updated risk evaluation and mitigation strategy (REMS).
The REMS now limits the use of rosiglitazone medicines to patients already being successfully treated with these drugs and those whose blood sugar cannot be controlled with other anti-diabetic treatments and do not wish to use Takeda's related drug Actos (pioglitazone) and variations thereof. The FDA added that after November 18, the GSK drugs will no longer be available through retail pharmacies.
This latest move looks pretty much like the end of the line for Avandia. Worldwide first-quarter sales slumped 79% to £36 million.
The views expressed in the following comments are not those of PharmaTimes or any connected third party and belong specifically to the individual who made that comment. We accept no liability for the comments made and always advise users to exercise caution.