Pulse Newsletter | Volume 7 - Issue 22

FDA Approves Drug to Treat Idiopathic Pulmonary Fibrosis

On October 7, 2025, the U.S. Food and Drug Administration (FDA) approved Jascayd® (nerandomilast) tablets for the treatment idiopathic pulmonary fibrosis (IPF) in adult patients. Pulmonary fibrosis (PF) is a type of chronic lung disease involving progressive lung inflammation and irreversible fibrosis, or scarring. The damage to the lungs makes breathing difficult for patients with PF. According to the Pulmonary Fibrosis Foundation, there are about 250,000 adults in the United States with PF. There may be a known cause associated with an individual’s diagnosis of PF, such as infection, adverse effects of certain medications or exposure to certain chemicals, such as asbestos. IPF is a type of PF with an unknown cause of origin. Older adults are more likely to be affected by IPF. Along with Jascayd®, other medications FDA approved for the treatment of IPF are Esbriet® (pirfenidone) and Ofev® (nintedanib). Oral steroids (prednisone, prednisolone) can also be used short-term to reduce inflammation. Jascayd® is available as an oral tablet, and the recommended dose of Jascayd® is 18mg taken by mouth twice daily with or without food. The dose may be reduced to 9mg twice daily for patients unable to tolerate the 18mg twice daily dose, except if the patient is also taking pirfenidone.

The safety and efficacy of Jascayd® was studied in a randomized, double-blind, placebo-controlled clinical trial, called FIBRONEER-IPF. The 52-week trial included 1,177 adult patients with IPF. Patients were randomly assigned Jascayd® 18mg twice daily, Jascayd® 9mg twice daily or placebo. Patients already on pirfenidone or nintedanib could continue their treatment during the clinical trial. The primary clinical endpoint in the FIBRONEER-IPF was change in forced vital capacity (FVC), which is a measure of an individual’s lung function taken by testing the amount of air they can forcefully exhale. The patients receiving Jascayd® in the trial experienced a better clinical outcome, as measured by a significantly smaller reduction in their FVC. In patients taking pirfenidone and assigned Jascayd® 9mg twice daily, clinical efficacy was not observed due to a reduction in Jascayd® concentrations. Therefore, the recommended dose of Jascayd® is 18mg twice daily when used together with pirfenidone. The most common side effects associated with Jascayd® during the study included diarrhea and decreased weight and appetite. Jascayd® is currently available with a list price of approximately $16,200 per month.

FDA Takes Action to Protect Children in the U.S. from Contaminated Cough Medicine Reported in India

On October 10, 2025, the FDA released information detailing their actions to prevent children inside the United States from being exposed to extremely dangerous contaminated over-the-counter cough medicine, which has been recently reported in India. The contaminated cough syrup was found to contain the poisonous industrial chemicals diethylene glycol (DEG) and ethylene glycol (EG), which are toxic to humans and can cause kidney failure. Reports show the contaminated cough syrup has led to the death of more than 20 children in India. The FDA has confirmed that the affected cough syrup products have not been shipped to the U.S. The contaminated products have been recalled in India, and the government of India has also confirmed that none were shipped outside of India.

The FDA has strict protocols in place to minimize the risk of contaminated drug products entering the U.S. Drug manufacturers have been reminded by the FDA that products distributed in the U.S. must meet Current Good Manufacturing Practice (CGMP) requirements and be appropriately inspected for product quality assurance. CGMP is a set of federal regulations that must be followed by drug manufacturers in the U.S., and for products entering the U.S., when manufacturing, processing and packaging a drug to make sure that the drug is safe and is accurately labeled with the correct ingredients. India is a large manufacturer of generic medications and vaccines, so it is important to remain vigilant in ensuring the highest level of quality control to prevent any future contamination. The World Health Organization (WHO), an agency of the United Nations that focuses on international public health issues, also has a protocol for testing and quality assurance, and has expressed their concerns over the failure of regulation and oversight in India allowing the contaminated cough syrup to be sold and consumed by children. The conditions under which the cough syrup was manufactured are cause for additional concern as an investigation reported contaminated water supply, poorly trained staff and lack of monitoring and quality assurance procedures. The federal government of India has responded by requiring all drug manufacturers in India to meet WHO standards by the end of 2025.

FDA Approves Oral Semaglutide for Risk of MACE for Patients with Diabetes

On October 17, 2025, the FDA approved Rybelsus® (semaglutide) to reduce the risk of major adverse cardiovascular events (MACE) in adult patients with type 2 diabetes mellitus at high risk for MACE. This is the second FDA-approved indication for Rybelsus®, which is also approved for the treatment of type 2 diabetes mellitus in adults. In addition to Rybelsus®, Ozempic® (semaglutide, initially approved for the treatment of type 2 diabetes mellitus), Wegovy® (semaglutide, initially approved for the treatment of obesity) and Trulicity® (dulaglutide, initially approved for the treatment of type 2 diabetes) also have FDA-approved indications to reduce the risk of MACE in adults. Rybelsus® is a glucagon-like peptide-1 (GLP-1) receptor agonist and is the only oral GLP-1 drug currently available. Other FDA-approved GLP-1 drugs to treat type 2 diabetes mellitus, such as Ozempic®, Trulicity®, Victoza® (liraglutide) and Mounjaro® (tirzepatide), are self-injected subcutaneously (under the skin). Oral semaglutide is being studied for treatment of obesity as well but is not currently FDA approved for this indication.

Although the exact mechanism of action of GLP-1 drugs is not known, these drugs act like the body’s natural GLP-1 hormone, stimulating insulin release from the pancreas when blood sugar is high. These drugs also slow digestion and reduce appetite, which typically results in consuming fewer calories leading to weight reduction when used in combination with diet and exercise. GLP-1 drugs have also been shown to help reduce inflammation in the body, which contributes to GLP-1 drugs successfully reducing risk of cardiovascular events. There are several other diseases currently under investigation for which GLP-1 drugs may be clinically beneficial, including osteoarthritis of the knee in adults with obesity, diabetic retinopathy and Alzheimer’s disease. Some new indications have already been FDA-approved, including Zepbound® for the treatment of moderate to severe obstructive sleep apnea (OSA) in adult patients with obesity, Wegovy® for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and Ozempic® to reduce risk of further kidney damage in patients with type 2 diabetes mellitus and chronic kidney disease. This area of drug development continues to be closely monitored for safety, efficacy and cost considerations.

New FDA Approvals

New Drug: Lasix® ONYU (furosemide)

Injection that is delivered through a pre-programed infusion device approved for the treatment of adult patients with edema (fluid retention) due to chronic heart failure. [10/7/2025 – SQ Innovation, Inc.]

New Generics Entering the Marketplace

Premarin® (conjugated estrogens)

Indication: For treatment of symptoms due to menopause

Dosage Form/Strength: 0.3, 0.45, 0.625, 0.9, and 1.25 mg tablets

Average Wholesale Price (AWP): Generic = $242 | Brand = $255