AstraZeneca and Bristol-Myers Squibb said Friday that the companies would pull their type 2 diabetes drug Forxiga (dapagliflozin) from the German market as of December 15 because of a dispute over its price. "The product will continue to be available by prescription until the current supply in the market is exhausted," the drugmakers said, adding that they will reconsider their decision once arbitration proceedings with German authorities are resolved.
The country's Federal Joint Committee had concluded that Forxiga conferred "no added benefit" over standard therapies, and the companies said they could not agree on a price with health-insurance administrators there. Forxiga was cleared by European regulators in November 2012, while an FDA advisory panel recommended the SGLT2 inhibitor for approval earlier this week. Bristol-Myers Squibb and AstraZeneca reported third-quarter sales of $7 million and $3 million, respectively, for the drug.
Germany's regulations have already prompted similar actions by other pharmaceutical companies, including GlaxoSmithKline, which pulled its epilepsy drug Trobalt (retigabine) from the German market in May 2012, as well as Boehringer Ingelheim and partner Eli Lilly, who decided against launching their diabetes therapy Trajenta (linagliptin) there over a dispute with the county’s reimbursement authority.
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