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2025 is expected to mark a pivotal moment for the pharmaceutical industry, as numerous noteworthy drug products are poised to seek FDA approval. The potential greenlighting of these groundbreaking therapies signifies the dawn of a transformative phase in medicine, focused on targeting essential unmet medical needs. At Buchanan, our FDA section is on the ground floor, actively monitoring and supporting novel drug product initiatives and ensuring that innovator companies are poised to navigate the regulatory landscape and protect their investment. In the following sections, we spotlight four particularly promising potential product approvals.

1. Suzetrigine

FDA is expected to make an approval decision on suzetrigine for moderate-to-severe acute pain by January 30. Suzetrigine is a non-opioid pain medication. In 2023, opioids were the  leading cause of fatal drug overdoses, with prescription opioids accounting for over 12% of these deaths. Although opioid-related fatalities have decreased slightly since 2022, these statistics underscore the need for non-addictive pain medication alternatives. While its efficacy for chronic pain is also under evaluation, these results are less promising.

FDA granted suzetrigine both fast track and breakthrough therapy designations. The fast-track designation facilitates the development and review of drugs that treat serious conditions and address unmet medical needs. The breakthrough therapy designation expedites the development and review of drugs intended to treat serious conditions when preliminary clinical evidence suggests that the drug may demonstrate substantial improvement over available therapy.

2. Semaglutide

Semaglutide is already FDA-approved for diabetes and weight loss, but its NDA holder is seeking two new indications in 2025. First, the NDA holder aims to obtain approval for semaglutide to lower the risk of events related to chronic kidney disease in adults with type 2 diabetes. Additionally, the NDA holder is pursuing approval to treat metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis.

Chronic kidney disease, characterized by a gradual loss of kidney function, is a common complication of type 2 diabetes. Nearly 1 in 10 Americans have type 2 diabetes, and this number is projected to triple by 2060. Therefore, medications that reduce the risks associated with chronic kidney disease in adults with type 2 diabetes have the potential to save many lives. Europe has already approved semaglutide for this indication, and the FDA is expected to review the application for this indication in the first half of 2025.

Additionally, according to a statement by the NDA holder, one in three overweight or obese individuals people live with MASH, a progressive liver disease that can be fatal if not properly managed. Nearly 75% of adults are overweight or obese in the United States, and the number of individuals with advanced stages of MASH is expected to double by 2030. Thus, this indication could similarly improve many lives. The NDA holder has not yet filed for FDA approval for this indication but plans to do so in the first half of 2025.

3. Nipocalimab

FDA is reviewing nipocalimab for several indications, including generalized myasthenia gravis, a chronic autoimmune disease that causes muscle weakness. Current treatments can slow disease progression but require continuous administration to maintain results. In contrast, nipocalimab demonstrated sustained disease control over a six-month period in a Phase 3 trial. Consequently, this therapy has the potential to help individuals with myasthenia gravis regain control of their lives.

FDA has also granted nipocalimab a breakthrough therapy designation for moderate-to-severe Sjögren’s disease and for treating alloimmunized pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN). Sjögren’s disease, a chronic autoimmune disease that causes the immune system to attack the glands that produce moisture in the body, affects approximately 1-4 million people in the United States. HDFN is a rare disease that occurs in pregnancies with maternal-fetal incompatibility in certain red blood cell types. Symptoms of HDFN can range from mild jaundice to life-threatening fetal anemia requiring invasive intervention. If approved for these indications, nipocalimab could represent a revolutionary advancement in treatment.

4. Fam-trastuzumab deruxtecan-nxki

FDA has granted fam-trastuzumab deruxtecan-nxki, which is already approved for five HER2-related indications, priority review for patients with HER2-low or HER2-ultralow metastatic breast cancer who have received at least one line of endocrine therapy. Priority review means that FDA aims to take action on the application within six months, compared to 10 months under standard review. This designation directs attention and resources on evaluating drugs that could significantly improve the treatment, diagnosis, or prevention of serious conditions.

The study supporting the application for the new indication found that patients with metastatic HER2-low and -ultralow breast cancer who received fam-trastuzumab deruxtecan-nxki lived approximately 13 months without cancer progression, compared to 8 months for those who received chemotherapy. It is estimated that 85% of people with metastatic, hormone receptor-positive breast cancer could benefit from fam-trastuzumab deruxtecan-nxki. 

A decision from FDA on the approval of this indication is expected in the first quarter of 2025.

As the pharmaceutical landscape continues to evolve, the role of experienced legal and regulatory guidance becomes increasingly vital. Buchanan’s FDA regulatory attorneys are readily available to assist you and your company in navigating the complexities of the FDA approval process and strategizing with you to ensure that groundbreaking therapies can reach the patients who need them most. With our support, stakeholders can confidently pursue their goals and contribute to the advancement of healthcare.