Boehringer's Ofev, Roche's Esbriet win same-day IPF approvals

The FDA played no favorites in the idiopathic pulmonary fibrosis (IPF) space – approving two new medicines on the same day on 15 October for the fatal lung disease, Boehringer Ingelheim's Ofev (nintedanib) and Roche's Esbriet (pirfenidone), despite the different timelines the drugs were on for the agency's nod.

The FDA played no favorites in the idiopathic pulmonary fibrosis (IPF) space – approving two new medicines on the same day on 15 October for the fatal lung disease, Boehringer Ingelheim's Ofev (nintedanib) and Roche's Esbriet (pirfenidone), despite the different timelines the drugs were on for the agency's nod.

More from Immunological

Equillium Seeks Accelerated Approval For GVHD Drug Despite Primary Endpoint Miss

 

The biotech is banking on itolizumab’s longer-term efficacy as well as unmet need in frontline acute graft-versus-host disease as it prepares to meet with the FDA.

Japan T-Reg Venture RegCell Raises New Funds, Relocates To US

 
• By 

Kyoto-based venture moves HQ to California to expand R&D and business outreach for its regulatory T-cell technology, as it raises around $46m in public and private funding.

Crunch Time Close For Abivax’s IBD Ambitions

 
• By 

Obefazimod has been heralded as a potential blockbuster for ulcerative colitis and there will be great interest in the readout of Phase III induction trials in the third quarter of this year.

Stelara Biosimilars Storm US Market With 85% Discounts Ahead Of Price Drop In Medicare

 
• By 

The development could highlight the power of competitive market forces over government price controls or suggest Medicare price negotiation is enhancing competitive market forces.

More from Therapy Areas

AstraZeneca Oral PCSK9 Prospects Pumped After Phase IIb Win

 
• By 

The UK giant is forecasting peak sales of $5bn plus

Novo Scores Cardio Wins But Lilly Still Tipped To Take GLP-1 Crown

 

Novo’s semaglutide has shown its benefits as an injectable in patients with peripheral arterial disease and as an oral agent in cardiovascular outcomes, but stronger results are expected soon from Lilly’s tirzepatide.

Sanofi Set To Shake Up Crowded Hemophilia Space After Qfitlia Approval

 
• By 

The small interference RNA therapeutic can be used by patients regardless of inhibitor status.