FDA Approves Boehringer Ingelheim's Ofev as First Kinase Inhibitor to Treat Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim Pharmaceuticals has announced that FDA approved Ofev (nintedanib) capsules for oral use for the treatment of idiopathic pulmonary fibrosis (IPF). Granted Breakthrough Therapy designation during its review by the FDA, Ofev, capsules for oral use, taken twice daily, is the only kinase inhibitor approved to treat IPF. Ofev0 will be available to patients within 10 days.
IPF is a rare and fatal lung disease that affects as many as 132,000 Americans. Most people with IPF only live 3–5 years after diagnosis. IPF typically affects men over the age of 65.
"While the cause of IPF is unknown and there is no known curative treatment, the unfortunate patients confronted with the disease and physicians caring for patients in the US have been anxiously awaiting FDA-approved treatments," said Ganesh Raghu, Professor of Medicine, University of Washington in the Division of Pulmonary and Critical Care Medicine and Director of Center for Interstitial Lung Diseases at University of Washington Medical Center, Seattle, WA. "In three clinical trials, nintedanib slowed lung function decline compared to placebo. This approval is a welcome development for patients and caregivers and it provides hope for those who are living with this devastating disease."
Decline in lung function, the primary endpoint, was measured by forced vital capacity (FVC in mL) over one year (annual rate of decline) versus placebo. FVC is the volume of air that can be forcibly exhaled after full inhalation.
In research, Boehringer Ingelheim discovered that nintedanib, a kinase inhibitor, blocks growth factor receptors implicated in IPF, including the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet-derived growth factor receptor (PDGFR).
"This approval is a major milestone in IPF with Ofev demonstrating a significant impact on the slowing of lung function decline and a significant reduction in the risk of a first acute exacerbation of IPF over 52 weeks," said Tunde Otulana, a pulmonologist and SVP, Clinical Development and Medical Affairs at Boehringer Ingelheim. "As a research-driven pharmaceutical company, moments like these, when we can bring a treatment option to patients who are very much in need, makes us extremely proud and inspires us to continue our quest for effective therapies to positively impact patients' lives."
Related News
-
News Pharmaceutical industry supports COP28 health stance in joint statement
As COP28 takes place over this week in Dubai, UAE, several bodies in the pharmaceutical and health industries have come together to announce support of key movements in sustainability in the sector, and to recognise sustainability as a health issue.&nb... -
News Biden backs Cold-War measures to shore-up medical supply chains
In a recent strategy to combat rising inflation and the cost of living crisis, President Joe Biden has invoked a Cold War-era act to increase investment in a selection of medicines and supplies. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Novartis agrees for copies to be made of cancer drug to reach poorer countries
Novartis signs agreement with MPP to have generics of it's leukemia drug made so that it can be more easily distributed to the world's poorer countries. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute. -
News New WHO health emergency guidelines expect full transparency from Big Pharma
The WHO are proposing a new set of pandemic guidelines to set out how future global health crises should be handled.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance