Latest news with #Brinsupri
WebMD
6 days ago
- Health
- WebMD
Brinsupri: First Once-Daily Tablet for Non-Cystic Fibrosis Bronchiectasis
What Is Brinsupri, and Why Does It Matter? Brinsupri (brensocatib) is a new oral medicine approved to treat a long-term lung disease known as non-cystic fibrosis bronchiectasis (NCFB) in adults and children ages 12 or older. It works by blocking an enzyme called DPP1, which normally activates certain proteins in white blood cells that cause inflammation in the lungs. By stopping this process, Brinsupri may help reduce lung damage and lower the number of flare-ups that result in worsening cough, increased mucus, shortness of breath, and fatigue that you may experience with NCFB. Brinsupri is the first and only medicine approved by the FDA that is made specifically for NCFB, which affects about 500,000 people in the U.S. and many more around the world. NCFB widens and damages the airways in your lungs, making it harder to clear mucus. This can lead to trouble breathing and frequent lung infections that often require antibiotics or hospital care while also affecting a person's emotional health and overall well-being. Until now, there were no approved treatments that directly targeted the inflammation behind this disease. Why Was It Approved? Brinsupri was approved because studies showed it was safe and effective in reducing the yearly number of flare-ups in people with NCFB. In one study, people who took Brinsupri (10 milligrams or 25 milligrams) had about 20% fewer flare-ups over a year than those who took a placebo. It also helped delay the time to the first flare-up and increased the number of people who didn't have any flare-ups during the study period. The higher dose also slowed down the worsening of lung function. The most common side effects included upper respiratory tract infections, headaches, skin rashes, dry or thickened skin, and high blood pressure, along with gum or dental problems. Less common side effects included changes in liver test results and thinning hair. The studies included adults and children aged 12 and older. Brinsupri has not been studied in children under 12, so it's not known if it's safe or effective for that age group. What Do I Need to Know? Brinsupri is a tablet you take once a day. It comes in 10-milligram and 25-milligram strengths and can be taken with or without food. If you miss a dose, just take your next dose at the usual time the next day. Don't take two doses at once to make up for a missed one. This medicine is now available in the U.S. through a specialty pharmacy network. Talk to your health care provider to see if Brinsupri is right for you, especially if you have skin or dental issues. Brinsupri may raise the risk for skin, gum, or tooth problems, so regular checkups with a dermatologist and dentist are a good idea. It is not known if Brinsupri affects how well certain vaccines work. Talk to your health care provider if you are planning to take a live, attenuated vaccine before or during your treatment. Let your health care provider know about all the medicines you take. Brinsupri may interact with other drugs, especially those that affect how your liver processes medicine. There's no safety information yet about using Brinsupri during pregnancy or while breastfeeding, so be sure to talk with your health care provider if you are pregnant, planning to become pregnant, or nursing.
Yahoo
6 days ago
- Health
- Yahoo
Insmed wins FDA approval for future blockbuster Brinsupri
Insmed's drug Brinsupri (brensocatib) has landed a double regulatory landmark win, becoming both the first marketed dipeptidyl peptidase 1 (DPP1) inhibitor and the first therapy for non-cystic fibrosis bronchiectasis (NCFB) approved by the US Food and Drug Administration (FDA). Brinsupri has been approved to treat adults and children aged 12 years and over with NCFB. The illness is a form of bronchiectasis not caused by cystic fibrosis, instead with airway damage arising from lung infections or inflammatory disorders, among others. Currently, bronchiectasis is treated through airway clearance procedures, antibiotic treatments, and exercise. However, until now, there has been no therapy specifically approved for the condition. Brinsupri, which is orally taken, is available in 10mg and 25mg tablets. GlobalData pharma analyst Vinie Varkey says: 'Brinsupri represents the first on-label non-antibiotic, anti-inflammatory treatment option that offers a more targeted action and possibly shift away from use of antibiotics in this disease space.' Shares in Nasdaq-listed Insmed closed 7.46% up at market close on 12 August and are currently trading around four times higher compared to a year ago, buoyed by the unveilings of positive clinical data. Brinsupri's approval was based on results from the Phase III ASPEN (NCT04594369) and Phase II WILLOW (NCT03218917) studies. ASPEN, which enrolled more than 1,700 NCFB patients, demonstrated a significant reduction in the annual rate of exacerbations for patients taking the medication. Exacerbations, also known as flare-ups, are endpoints often used in respiratory disease trials to measure therapy efficacy. Patients who received a 10mg dose of Brinsupri had a 21% reduction compared to those on placebo, while those who received a 25mg dose exhibited a 19% reduction. Varkey adds: 'As the first-to-market DPP-1 inhibitor in the respiratory field, Brinsupri is likely to become the standard of care in NCFB treatment. Key opinion leaders interviewed by GlobalData were excited by Brinsupri's ability to reduce exacerbations and slow the rate of lung function decline.' Insmed confirmed that applications for its drug have also been sent to the European Medicines Agency (EMA) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA), with commercial launches anticipated in 2026. Brinsupri is already available in the US by prescription through a comprehensive speciality pharmacy network. The future for Brinsupri is looking bright in its untreaded indication. GlobalData reckons Insemed has a blockbuster on its hands, forecasting sales of $1.7bn by 2033. In an investor presentation, Insmed stated the drug could generate $5bn in peak sales. Around 500,000 people in the US are estimated to have NCFB, according to Insmed. GlobalData forecasts the bronchiectasis market to be worth $3.7bn in 2033 across the 8MM (US, France, Germany, Italy, Spain, UK, Japan, China). GlobalData is the parent company of Pharmaceutical Technology. Brinsupri joins the market alongside Insmed's only other commercial therapy, Arikayce (amikacin), approved in 2018 to treat Mycobacterium avium complex (MAC) lung disease. Varkey adds: 'For Insmed itself, Brinsupri's approval will be one that is instrumental in catapulting the company's profile as a key player within the respiratory space.' Her comments highlight an opportunity for DPP-1 inhibitors to expand into other respiratory indications, highlighting further growth avenues for biopharmas. "Insmed wins FDA approval for future blockbuster Brinsupri" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
UPI
6 days ago
- Health
- UPI
First drug to treat bronchiectasis lung condition approved by FDA
The U.S. Food and Drug Administration has approved Insmed's daily bronchiectasis pill, brensocatib, which will be sold under the brand name Brinsupri. File Photo by John Angelillo/UPI | License Photo For the first time, people with bronchiectasis will have a treatment option. The U.S. Food and Drug Administration has approved Insmed's daily pill brensocatib, which will be sold under the brand name Brinsupri. The drug is designed to treat non-cystic fibrosis bronchiectasis, a chronic condition that damages the lungs and makes it harder to clear mucus, the company said in a statement. The approval comes after the medication succeeded in one of last year's most closely watched Phase 3 clinical trials. The company says Brinsupri could become a blockbuster, estimating peak sales at $5 billion a year, STAT News reported. "The FDA approval of the first-ever treatment for non-cystic fibrosis bronchiectasis is a historic milestone for patients and for Insmed," the company's chief medical officer, Dr. Martina Flammer, said in a statement. The American Lung Association estimates that bronchiectasis affects between 350,000 and 500,000 adults in the United States. It happens when the airways in the lungs become widened, thickened and scarred - often after an infection or other damage. This makes it difficult to clear mucus, allowing germs and particles to build up and cause repeated lung infections. Brinsupri works by blocking an enzyme called DPP1. Insmed bought the drug from AstraZeneca for $30 million and is also testing it for other conditions, such as chronic rhinosinusitis, STAT News reported. The company plans to sell the drug in the U.S. at an annual list price of $88,000. It has also filed for approval in Europe and the United Kingdom, and it plans to do so in Japan. "For the first time, we have a treatment that directly targets neutrophilic inflammation and addresses a root cause of bronchiectasis exacerbations. Based on the strength of the data and the impact we've seen in patients, I believe this could become the new standard in non-cystic fibrosis bronchiectasis care." Dr. Doreen Addrizzo-Harris, a pulmonary and critical care physician and director of the NYU Langone Health Bronchiectasis and NTM Program in New York City, said in a news release. More information The American Lung Association has more about bronchiectasis. Copyright © 2025 HealthDay. All rights reserved.
Yahoo
7 days ago
- Business
- Yahoo
FDA Approves Insmed's Drug As First Treatment For Type Of Chronic Lung Disease
The U.S. Food and Drug Administration (FDA) on Tuesday approved Insmed Incorporated's (NASDAQ:INSM) Brinsupri (brensocatib 10 mg and 25 mg tablets). It is an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older. Brinsupri is the first and only FDA-approved treatment for NCFB, a chronic lung condition characterized by permanently widened and damaged airways (bronchi), leading to persistent mucus production, recurrent infections, and difficulty breathing. There are approximately 500,000 people in the U.S. diagnosed with NCFB. The approval is based on data from the Phase 3 ASPEN and Phase 2 WILLOW ASPEN, patients taking Brinsupri 10 mg or 25 mg had a 21.1% and 19.4% reduction in the annual rate of exacerbations, respectively, as compared to placebo. Both dosage strengths of Brinsupri also met several exacerbation-related secondary endpoints, including significantly prolonging the time to first exacerbation and significantly increasing the proportion of patients remaining exacerbation-free over the treatment period. Patients who received Brinsupri 25 mg experienced a statistically significantly less decline in lung function, as measured by forced expiratory volume in one second (FEV₁) after using a bronchodilator, at week 52. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions in WILLOW. In parallel, applications for brensocatib with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have been accepted, and the company plans to file in Japan in 2025. Commercial launches are anticipated in 2026, pending approval in each territory. Price Action: INSM stock is up 6.20% at $119.89 at the last check on Tuesday. Read Next:Photo: Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? INSMED (INSM): Free Stock Analysis Report This article FDA Approves Insmed's Drug As First Treatment For Type Of Chronic Lung Disease originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Reuters
7 days ago
- Health
- Reuters
US FDA approves Insmed's drug as first treatment for a chronic lung disease
Aug 12 (Reuters) - The U.S. Food and Drug Administration has approved Insmed's (INSM.O), opens new tab oral drug for a type of lung disease, the company said on Tuesday, making it the first treatment for the chronic condition. Shares of the New Jersey-based drugmaker rose 6% in morning trade. Insmed's drug, branded as Brinsupri, targets non-cystic fibrosis bronchiectasis, a chronic lung condition characterized by permanently damaged airways, leading to persistent cough and excessive mucus production. The condition affects 350,000 to 500,000 adults in the U.S., according to the American Lung Association. Brinsupri works by blocking certain inflammatory enzymes in white blood cells, preventing them from becoming overactive and damaging the lungs. Earlier treatments for the condition focused on controlling symptoms by using antibiotics, surgery or devices such as flutter valves to clear the airways. Insmed's application was based on a late-stage trial involving 1,680 adult and 41 adolescent patients, with the drug significantly reducing the frequency of respiratory symptoms such as chronic cough. The drug was found to be safe and well-tolerated at the two tested doses of 10 milligrams and 25 milligrams. TD Cowen analyst Ritu Baral expects the drug to reach peak sales of $3.7 billion in the United States by 2031. Brinsupri has the potential to drive future profitability for the company, she said. Rival treatments in development for the chronic lung condition include AstraZeneca's (AZN.L), opens new tab benralizumab and Zambon's inhaled antibiotic therapy CMS I-neb. This marks the second FDA approval for Insmed following Arikayce, which the agency cleared in 2018 to treat a chronic lung infection caused by bacteria commonly found in soil and water.
