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Dapagliflozin’s Commercial Appeal Could Dim With Bladder Cancer Concerns

 
• By Sue Sutter

Lingering questions surrounding an imbalance in bladder cancer cases – and how FDA decides to handle the issue in labeling – could threaten the diabetes drug’s uptake, particularly given the absence of a similar signal for J&J’s competing SGLT-2 inhibitor Invokana, already on the market.

Though it now has an FDA advisory committee endorsement in its pocket, Bristol-Myers Squibb Co. and AstraZeneca PLC’s Farxiga (dapagliflozin) could face a difficult competitive environment if approved, given lingering concerns about bladder cancer risk and restrictions against use in type 2 diabetics with moderate to severe renal impairment.

The safety-related concerns, coupled with its second-in-class status, could prove a challenge for dapagliflozin as it attempts to cut into...

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More from United States

Ultragenyx Says CRL Discussions ‘Productive’ Despite US FDA Leadership Upheaval

 
• By Jessica Merrill

Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.

Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 
• By Sarah Karlin-Smith

Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.

More Telework, More Staff, US FDA’s Tidmarsh Plans To Alleviate Workforce Challenges

 
• By Sarah Karlin-Smith

The new CDER director focused on plans to improve morale during an Aug. 8 townhall, but staff comments indicate that may be a challenge.

US Pricing Reform: New Products Offer ‘On Ramp’ To Implementation, Lilly’s Ricks Says

 
• By Cathy Kelly

Eli Lilly's CEO argued that pricing reforms aimed at existing drugs would be “hard to sustain or justify,” while other companies suggested a growing interest in direct-to-consumer sales programs.

More from North America

New US FDA CDER Director Pledges No Politics In Approvals, Adds Higher Ups Can Overturn

 
• By Sarah Karlin-Smith

New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.

EU Must Up Competitiveness To Counter US Tariffs And Pricing Woes For SMEs

 
• By Francesca Bruce

Companies in Europe cannot delay business decision making much longer to wait for more certainty on major US policy shifts on tariffs and pricing.

HHS mRNA Vaccine Funding Cut Impact Limited (And One Contract Isn’t Even mRNA)

 
• By Alaric DeArment

HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.