The British papers love a medical breakthrough almost as much as a political crisis. And that willingness to fawn over efficacy data, even from a small study, was on full display with the recent hype over fevipiprant, Novartis’s pill for severe asthma.
Reporting in the prestigious pages of The Lancet, investigators say that the CRTh2 antagonist – now in Phase III with a 2019 launch date planned – dramatically reduced levels of eosoniphils, a key biomarker for moderate to severe asthma. Adding the drug to standard of care massively reduced the levels of eosinophils, which dropped from an average of 5.4% to 1.1% — nearly normal – in the trial, which enrolled a total of 61 patients.
“This new drug could be a game changer for future treatment of asthma,” noted Professor Chris Brightling, an NIHR senior research fellow at the University of Leicester. The Guardian noted that the drug could revolutionize treatment.
Just to make sure that message got across loud and clear, the investigators included a testimonial from a patient who claimed to have a whole new lease on life after taking the drug.
“For me, it felt like a complete wonder drug and I can’t wait for it to be available because I really think it could make a huge difference to me,” said Gaye Stokes from Grantham in Lincolnshire, who has had severe asthma for 16 years. She took part in the trial and was part of the Fevipiprant group. “I knew straight away that I had been given the drug. I felt like a completely different person. I had more get up and go, I was less wheezy and for the first time in years I felt really, really well.”
Aside from cherry picking a patient to tout the drug’s therapeutic potential, the breathless release also overlooks the simple fact that the CRTh2 pathway on eosoniphils is by no means virgin territory. Boulder, CO-based Array BioPharma has posted positive mid-stage data on its own CRTh2 pill ARRY-502, back in 2014. And AstraZeneca (benralizumab), GlaxoSmithKline Nucala (mepolizumab) and Teva have all been angling for a share of the asthma market with eosoniphilic antibodies that have blockbuster potential. And the press overlooked another Phase II failure for this drug, measuring lung capacity.
Worth noting fevipiprant failed to meet FEV1 endpoint in a larger Ph2 trial in uncontrolled allergic asthma recently https://t.co/EO6lBzE5Wc
— Mark Lansdell (@DatamonitorMark) August 6, 2016
The giant Novartis has pegged the drug as a potential first-in-class player in a huge market. It now has a bona fide media frenzy to help amp up its claims, three years ahead of a possible approval.
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