More than 10 years after bringing one of the first idiopathic pulmonary fibrosis (IPF) drugs to market, Boehringer Ingelheim is freshening up its leadership in the rare lung disease space with a newly approved treatment option.
Jascayd's Oct. 7 FDA approval makes it the first new therapy for IPF in more than a decade, following in the footsteps of the company's own Ofev and Roche’s Esbriet, which won their respective FDA nods back in 2014. Together, those two medicines make up the current therapeutic market for IPF in the U.S.
With a tolerability edge over the older treatments and proven benefits in lung function, Boehringer’s new option could “shape the future of IPF treatment,” Martin Beck, head of the company’s inflammation disease area, told Fierce Pharma in an interview.
In trials, treatment with the oral twice-daily drug—also known as nerandomilast—resulted in a significantly smaller decline in patients' forced vial capacity (FVC) compared with those who received placebo. FVC is a common lung disease endpoint that measures the maximum amount of air a person can forcefully exhale after taking a deep breath.
Jascayd’s benefits in slowing lung function decline and boosting lung volume could make the drug a crucial option for IPF patients, who face a progressive worsening of disease that causes more than half of patients to die within five years of diagnosis, Beck said.
The disease is more deadly than many common cancers and could impact up to 3.6 million people across the globe, according to Boehringer. But, because it’s underdiagnosed and often misdiagnosed, only about 167,000 patients are currently receiving treatment, leaving a major gap in the market, Beck pointed out.
While the drug didn’t meet the criteria to demonstrate a statistically significant survival benefit, it showed a “nominally significant reduction in risk of death” in patients with IPF and those with the related disease progressive pulmonary fibrosis (PPF), Boehringer announced last month, citing a pooled analysis.
Still, Jascayd's profile represents a notable step forward in the IPF space, Beck said, describing the field as a “graveyard of clinical development” populated by more than 36 failed trials over the past decade.
Now, the company is ready to make sure patients can access the new treatment option “as quickly as possible,” Beck said. Boehringer is poised to supply the drug “within days,” because “every day counts” for IPF patients, he added.
“This is really a chance for those patients to have a chance to keep breathing, keep living,” the exec explained.
Boehringer’s 10-plus years of experience in the IPF space with Ofev give the company a foundation for Jascayd's market entry. Still, Ofev is by no means old news as it remains a top seller for Boehringer, garnering $4 billion in sales last year.
“To lead the next wave of innovation with nerandomilast is a true privilege for us at Boehringer and reflects our deep heritage in respiratory medicine as well as our unwavering commitment to additional treatment options for people living with IPF,” Shashank Deshpande, Boehringer’s head of human pharma, said in a statement.
However, it remains to be seen whether Jascayd can live up to its blockbuster predecessor.
Leerink analysts expect “solid uptake” on the drug given the limitations of the older treatments, the team wrote in a note to clients. But they argued the drug is a “modest advance due to relatively modest effect-size on lung function," which leaves room for future entrants.
Jascayd’s approval is a "sign of a turning tide" in IPF drug development and a signal that the standard of care will look “significantly different” in the years to come, the analysts wrote in a note to clients.
Several other companies are looking to get in on the IPF space, giving Boehringer plenty of competition on the horizon. United Therapeutics' nebulized inhalation solution Tyvaso, for one, delivered a phase 3 win last month in what United execs called “overwhelmingly positive” results.
United and Boehringer are both also studying their respective drugs in PPF, another indication Boehringer is pursuing with the FDA.