Just two months after reviving its prowess in the idiopathic pulmonary fibrosis (IPF) treatment area with rare lung disease med Jascayd, Boehringer Ingelheim is already unlocking another patient population with a new FDA nod.
The new approval for Jascayd in progressive pulmonary fibrosis (PPF) makes the drug the only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects approved in this indication, according to a Dec. 19 company press release.
“Progressive pulmonary fibrosis is a life-threatening condition with a high unmet medical need. The U.S. approval of Jascayd is an important step forward to help slow lung function decline for people living with PPF, providing a new, well-tolerated treatment option,” Boehringer’s head of human pharma, Shashank Deshpande, said in a release.
Boehringer expects additional global approvals for the Jascayd in 2026 and has filed regulatory submissions in both IPF and PPF that are currently under review in Europe, the U.K., Japan and other countries. Regulators in China have already followed the FDA’s lead in October with a nod for the drug in IPF.
PPF impacts up to 5.6 million people globally and up to 100,000 people in the U.S., according to the company. The disease is linked to an underlying diagnosis of clinical interstitial lung disease (ILD) that can come in a handful of forms, such as autoimmune ILDs, hypersensitivity pneumonitis or unclassifiable idiopathic interstitial pneumonia, to name a few, but it can also be caused by environmental exposure to toxins or other unknown causes.
Diagnosis is typically delayed by up to two years on average, Boehringer said, while up to half of those diagnosed still remain untreated.
The underlying conditions key to the disease can render the lungs “overlooked,” but can lead to a “debilitating and irreversible impact on lung function,” highlighting the need for new treatment options, McGovern Medical School’s director of rheumatology, Shervin Assassi, M.D., explained in Boehringer’s release.
The company tested Jascayd’s benefits in the new indication through the largest clinical trial program in PPF to date, finding that the drug can slow lung function declines.
Fiobroneer-ILD specifically evaluated Jascayd against placebo on changes from baseline in forced vital capacity (FVC), a common lung disease endpoint that measures the maximum amount of air a person can forcefully exhale after taking a deep breath. At week 52, patients on 18 mg or 9 mg of treatment saw a mean decline from baseline of -86 mL and -69 mL, respectively, compared to -152 mL in the placebo group.
The key secondary composite endpoint was measured as time to first occurrence of acute ILD exacerbation, hospitalization for respiratory cause, or death over the blinded duration of the trial. Ultimately, the company found no statistically significant treatment difference between either of the two Jascayd doses and placebo.
However, an exploratory analysis showed that Jascayd in its 18 mg dose strength showed a “nominally significant reduction” in the risk of acute ILD and hospitalization over that blinded trial duration, which spanned up to 109 weeks.
Boehringer’s IPF study using the same primary and key secondary endpoints yielded similar outcomes, meeting the FVC primary endpoint but missing the secondary measure.
Breaking through a lung disease drought
Even so, Jascayd’s October nod in IPF marked the first new treatment option for the rare lung disease in over a decade, breaking a drought that followed the 2014 approvals of Boehringer’s own Ofev and Roche’s Esbriet. Until now, the even rarer PPF subset’s only on-label treatment option was Ofev, which added on a 2020 indication that covers ILDs with a progressive phenotype.
While Jascayd’s launch will surely benefit from Boehringer’s 10-plus years of experience in the IPF space, it remains to be seen if the newer drug can take the IPF crown from Ofev. The older drug is still a top seller for Boehringer, garnering $4 billion in sales last year. Jascayd, meanwhile, could be in line for “solid uptake,” but the new entrant itself leaves room for future rivals due to its “relatively modest effect-size on lung function,” Leerink analysis explained in a previous note to clients.
With Jascayd receiving the FDA’s blessing in both of its studied indications, Boehringer is on a roll heading into 2026. Both of its key new drugs in Jascayd and lung cancer med Hernexeos earned fourth-quarter approvals, with the latter up for a speedy review in an expanded indication as the recent recipient of a Commissioner’s National Priority Voucher from the FDA.