FDA asks for further data on AstraZeneca, Bristol-Myers Squibb’s dapagliflozin

AstraZeneca and Bristol-Myers Squibb said Thursday that the FDA requested further data in a complete response letter regarding the companies’ filing for the type 2 diabetes therapy dapagliflozin. The drugmakers noted that the agency has asked for “additional clinical data to allow a better assessment of the benefit-risk profile” for the compound, including results from ongoing studies, and also “may require information from new clinical trials.”

In October, the regulator extended its review of dapagliflozin by three months to January 28 to allow it time to assess additional data requested from AstraZeneca and Bristol-Myers Squibb. The decision followed an advisory panel’s earlier recommendation against approving the drug due to concerns about a potential risk of breast and bladder cancer. The FDA panelists also cited possible liver and kidney risks associated with the once-daily agent, especially among elderly patients.

The companies said that they “remain committed to dapagliflozin and its development” and would work with the FDA “to determine the appropriate next steps.” AstraZeneca and Bristol-Myers Squibb noted they are also “in ongoing discussions with health authorities in Europe and other countries as part of the application procedures.” AstraZeneca spokeswoman Esra Erkal-Paler remarked that “it’s quite likely we will try to meet with the FDA within the next three months.” She added that with regards conducting a new clinical trial, “we need to wait and talk with the FDA to see what the next appropriate step is that we need to take.”

However, WestLB analyst Mark Belsey suggested that given dapagliflozin’s cancer risk and liver toxicity, it was unlikely that AstraZeneca would conduct another clinical trial. “While not a major financial contributor for either company, dapagliflozin’s delay will likely be viewed as a setback nonetheless,” remarked Sanford C. Bernstein & Co. analyst Tim Anderson. Analysts predict that if approved, the potential first-in-class SGLT2 inhibitor could generate sales of $562.7 million in 2016 for Bristol-Myers Squibb and $164.5 million for AstraZeneca.

Belsey added that “it still feels like there’s a big hole in terms of new products” in AstraZeneca’s pipeline. The company recently announced it would record a charge of $381.5 million in the fourth quarter of 2011, related to setbacks in the development of olaparib for ovarian cancer and TC-5214 for major depressive disorder. “There’s really not much there in the pipeline that’s particularly compelling,” Belsey commented.