The US Food & Drug Administration (FDA) approved nerandomilast (Jascayd) tablets for idiopathic pulmonary fibrosis (IPF), the first new product for the progressive lung condition in more than 10 years, reports Medpage Today.
Primary support for the preferential inhibitor of phosphodiesterase 4B (PDE4B) came from two phase 3 trials, which at two different doses demonstrated significantly smaller mean declines in forced vital capacity (FVC) at one year:
• FIBRONEER-ILD: 98.6 mL and 84.6 mL with the 18-mg and 9-mg nerandomilast doses vs 165.8 mL with placebo (both P<0.001)
• FIBRONEER-IPF: 114.7 mL and 138.6 mL with the two doses, respectively, as compared with 183.5 mL with placebo (P<0.001 and P=0.02)
Pooled data from the trials also suggested a potential reduction in death with the PDE4B inhibitor as well, said drugmaker Boehringer Ingelheim. The class of drug represents a new mechanism in IPF, exerting both antifibrotic and immunomodulatory effects.
“This represents a new era in the treatment of IPF, a rare and debilitating chronic condition that worsens lung function. Nerandomilast has proven to slow lung function decline in the disease,” said investigator Tony Maher, MD, PhD, of the Keck School of Medicine at the University of Southern California-Los Angeles.
IPF is a rare disease marked by fibrosis in the alveoli of the lungs. It is typically diagnosed in adults in their 60s or 70s, and common symptoms include dyspnoea and cough. Progression and scarring can happen quickly for some patients, but the disease course varies, according to the FDA.
Nerandomilast tablets can be taken with or without food at a dose of 18mg twice-daily, roughly 12 hours apart. If tolerability issues arise, some patients can have their dose reduced to 9mg twice-daily. Those on pirfenidone (Esbriet) should only take the 18mg dose, as the lower dose did not demonstrate an FVC benefit in this subset.
Adverse events occurring in at least 5% of nerandomilast-treated patients included diarrhoea, Covid-19, upper respiratory tract infection, depression, fatigue, headache, nausea or vomiting, back pain, dizziness, and decreases in weight and appetite.
Drug discontinuation for toxicity happened more often with the PDE4B inhibitor, ranging from 12%-15% as compared with 11% with placebo; diarrhOea was the most common reason.
No contraindications are noted in the labelling, but drug interactions could occur with strong CYP3A inhibitors and moderate or strong CYP3A inducers, the FDA said.
Medpage Today – FDA Approves First New Drug for Deadly Lung Condition in Over a Decade (Open access)
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