FibroGen May Have A New Opening For Roxadustat In The US

The company announced positive Phase II data for roxadustat in chemotherapy-induced anemia.

Two Roads
FibroGen could have another path to take forward for roxadustat • Source: Alamy

Just weeks after FibroGen, Inc.'s lead asset roxadustat failed to win approval from the US Food and Drug Administration for anemia in chronic kidney disease, the company announced positive clinical trial data for the drug in a different indication, chemotherapy-induced anemia. The results of the Phase II WHITNEY trial released on 25 August could provide an opportunity for FibroGen to pivot to the chemotherapy-induced anemia indication in the US.

Earlier in August, FDA issued a complete response letter (CRL) for roxadustat in CKD – a big disappointment for FibroGen...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Blood and Clotting

BMS/Pfizer To Sell Discounted Eliquis Direct – And Other Drugmakers May Follow Suit

 

Analysts see the new strategy as a way to address pressure from the Trump administration’s most favored nation drug pricing proposals.

Hopes Rise For Sickle Cell Gene Therapy Access As 33 States Join CMS Program

 

CMS said that 33 US states plus the District of Columbia and Puerto Rico had joined a program whereby the agency negotiates outcomes-based contracts on their behalf.

BioMarin’s Roctavian Continues to Shine In Hemophilia A Despite Commercial Woes

 

Roctavian shows durable bleed control and safety over five years, but high costs and access hurdles limit its commercial outlook.

Pfizer’s Hympavzi Poised For Broader Hemophilia Label

 

The drugmaker announced positive topline results for the drug in hemophilia A and B patients with inhibitors, on top of the existing approval for patients without inhibitors.

More from Therapy Areas

Vertex’s Pain Drug Failure Adds To Investor Doubts

 

A Phase II trial to develop a second NaV1.8 pain signal inhibitor for acute pain has failed and the US FDA has given a thumbs down on Journavx’s path to broader use in peripheral neuropathic pain.

Cardiff Pushes Towards Colorectal Cancer Phase III As Funding Questions Loom

 
• By 

Cardiff Oncology is open to going it alone, a partnership and even an exit as the San Diego, CA-based firm tries to push its PLK1 inhibitor through late-stage development.

Aurigene Oncology CEO On Biotech Valuations, CAR-Ts And Reimbursement Models

 

Aurigene Oncology CEO talks in this audio interview about the tough biotech funding environment, pipeline assets including a CAR-T therapy in Phase II, "hybrid" manufacturing, outcome-based reimbursement and the promise of bispecifics and multispecifics, including Akeso's PD-1/VEGF bispecific.