 
FDA Approves Drug for Chronic Inflammatory Lung Condition in Patients 12 and Older
This Approval is the First Treatment for Non-Cystic Fibrosis Bronchiectasis
Today, the U.S. Food and Drug Administration approved Brinsupri (brensocatib) tablets to treat non-cystic fibrosis bronchiectasis (NCFB), a chronic inflammatory lung condition, in patients ages 12 years and older.
NCFB is a progressive respiratory condition that can lead to complications and death. Patients with this disease experience frequent cough, shortness of breath, and recurrent infections due to the damage the disease causes to the lungs. NCFB can develop because of previous lung infections, chronic pulmonary obstructive disease, autoimmune diseases (where the body’s immune system attacks itself), and immunodeficiencies (where the immune system does not work properly). There are between 230,000 and 430,000 U.S. cases of NCFB.
There have been no approved therapies for NCFB. Before today’s action, patients relied on antibiotics and symptom management, such as physiotherapy, supplemental oxygen, and mucolytics, which are medications to loosen mucus.
Brinsupri works by inhibiting the enzyme dipeptidyl peptidase, which helps stop the inflammatory processes that cause NCFB. The drug’s effectiveness and safety were demonstrated in two multicenter, randomized, double-blind, placebo-controlled clinical trials that enrolled a total of 1,915 adults and 41 adolescents with NCFB. Clinical trial participants received either 10 mg or 25 mg of Brinsupri or placebo once daily for up to 52 weeks.
In one trial, the primary measure of Brinsupri’s efficacy was measured by looking at the rate of flare-ups over 52 weeks, which were defined as worsening of three or more major symptoms (e.g., cough, breathlessness, fatigue) over 48 hours that required antibiotics. Participants taking Brinsupri 10 mg and 25 mg had lower annualized rates of flare-ups compared to placebo. These participants had a longer time until their first flare-up on both doses compared to placebo. In the other trial, individuals taking both doses of Brinsupri also experienced a longer time until the first flare-up compared to placebo.
Brinsupri has a warning for dermatologic (skin) reactions and its label notes the need to see a dermatologist for new rashes or skin conditions. Brinsupri also has a warning for gingival and periodontal (gum and tooth) problems and its label notes the importance of seeing a dentist while on the drug. The most common side effects include upper respiratory tract infections, headache, rash, dry skin, hyperkeratosis (skin thickening), and hypertension. Less common side effects include increase in liver function blood tests, alopecia (hair loss), and certain skin cancers.
FDA granted the approval to Insmed Inc. Brinsupri received breakthrough therapy designation and was reviewed on a priority timeline.
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