CHMP backs first drug for lung disease bronchiectasis

The list of new medicines recommended for approval at the October meeting of the EMA's human medicines committee includes Brinsupri, the first treatment for serious chronic lung disease non-cystic fibrosis bronchiectasis (NCFB).

Insmed's DPP1 inhibitor Brinsupri (brensocatib) has been recommended by the CHMP for the treatment of patients aged 12 and older with NCFB, a debilitating condition in which the walls of the airways become thickened and damaged as a result of a cycle of inflammation and infections.

The disease can be hard to diagnose, which explains why the estimated number of patients with NCFB in the EU varies between a conservative figure of 400,000 and around three million. Insmed has said it thinks the high prevalence of the disease could help drive Brinsupri sales to a peak of $5 billion a year or more.

Insmed's drug – which was also approved in the US in the summer – should be an option for patients who have had two or more exacerbations or flare-ups in the prior 12 months, according to the committee.

Patients typically experience between one and four exacerbations per year, which can lead to progressive lung damage, repeated infections requiring antibiotic treatment, reduced quality of life, and an increased risk of early death.

Brinsupri has been approved on the back of the ASPEN trial, which showed that the drug cut the number of attacks experienced in a year by around 29% compared to placebo, whilst also prolonging the time to a first exacerbation and increasing the chances of patients becoming exacerbation-free over 52 weeks of follow-up.

The European Commission should now approve Brinsupri within the next few weeks, and Insmed is also hoping to bring the drug to the Japanese market next year.

Other decisions

Also at the CHMP meeting, Sanofi's BTK inhibitor Wayrilz (rilzabrutinib) was recommended as a treatment for adults with immune thrombocytopenia (ITP), a rare autoimmune blood disorder, who are refractory to other treatments.

Wayrilz was approved in the US a few weeks ago for a similar indication., becoming the first drug in the BTK inhibitor class for ITP.

The committee recommended not granting a marketing authorisation for Sanofi Winthrop's Rezurock (belumosudil), a medicine intended for the treatment of chronic graft-versus-host disease (GvHD), a condition in which donor cells attack the body's organs after a transplant, despite an urgent need for new treatment options. The CHMP said the clinical data submitted for the drug was not strong enough to show efficacy.

Sanofi acquired Rezurock as part of its $1.9 billion takeover of Kadmon Pharma in 2021. The drug remains on the market in the US, and Sanofi now has a 15-day window to request a re-examination of the CHMP's decision.

Photo by National Cancer Institute on Unsplash