Although 2024 saw some key FDA approvals, including the first new schizophrenia treatment in decades and a first in-class immunotherapy for a tough-to-treat cancer, 50 regulatory decisions didn’t quite match 2023’s banner year of 55 novel FDA nods.
But that could change in 2025, predicted Sara LaFever, executive director, product services, for Citeline.
“We think that [in] 2025 we’ll probably start seeing an uptick again, perhaps similar to those 2023 numbers,” she said.
Some big R&D programs are approaching the market this year, from a non-opioid pain med to a potential myasthenia gravis game-changer, as well as new indications for weight loss and cancer.
Here are four possible approvals to watch in 2025.
The first new pain class in decades
Developer: Vertex Pharmaceuticals
Drug: suzetrigine
Why it matters: A non-opioid pain medication that’s non-addictive and has a better safety profile than standard treatments would be a big deal for patients who haven’t had a new option in decades. Promising phase 3 data points to suzetrigine as a potential entry.
The drug, which was granted FDA fast track and breakthrough therapy designations in moderate-to-severe acute pain, could “change the paradigm of pain management as we know it,” according to the company. The potential approval is especially significant considering how the opioid crisis has impacted drug development, with research showing it discouraged investments and research into new pain treatments.
The FDA is slated to render a decision for suzetrigine in moderate-to-severe acute pain by Jan. 30. The treatment is also being tested in chronic pain where it recently demonstrated less encouraging results.
An expanded label for a diabetes and weight loss juggernaut
Developer: Novo Nordisk
Drug: semaglutide
Why it matters: Novo Nordisk’s diabetes and weight loss drugs Ozempic and Wegovy have been nothing short of a phenomenon, both clinically and culturally. Now, the company is looking to expand the active ingredient semaglutide into more uses, lowering the risk of events related to chronic kidney disease in adults with type 2 diabetes and for two liver conditions.
The company already scored the added CKD indication in Europe and expects the FDA’s decision on that label expansion in the first half of 2025. It plans to file for regulatory approvals in the U.S. and EU in the first half of 2025 for metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis after announcing positive results for each in a pivotal phase 3 trial in November.
The kidney and liver indications would be the latest in a string of label expansions for semaglutide. In March last year, Wegovy snagged FDA approval to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease who are either obese or overweight. Added indications for Ozempic and Wegovy would be good news for the company, which saw its shares tumble in December after it released disappointing phase 3 data for its “next-generation” weight loss drug, CagriSema, which was poised to provide another competitor against Eli Lilly’s Mounjaro.
“Everyone’s paying attention to the obesity space,” said LaFever.
A hot indication may be the first of many
Developer: Johnson & Johnson
Drug: nipocalimab
Why it matters: J&J took a $6.5 billion risk in 2020 when it acquired immune-mediated disease specialist Momenta Pharmaceuticals and its lead asset, the monoclonal antibody nipocalimab in 2020. The pharma giant could see that wager pay off in 2025 if it scores the first of several anticipated approvals for nipocalimab in myasthenia gravis, a competitive indication.
“Everything in myasthenia gravis is being watched really hard,” said LaFever. Myasthenia gravis is a chronic disease in which autoantibodies proliferate uncontrollably — while current treatments can successfully hold back the disease, they must be sustained, but nipocalimab could potentially allow patients “to reclaim their lives,” said Dr. Katie Abouzahr, vice president, autoantibody portfolio and maternal fetal disease area leader, J&J Innovative Medicine, in an interview last year.
J&J submitted a biologics license application for nipocalimab in August for generalized myasthenia gravis, a chronic autoimmune disease that causes skeletal muscle weakness. Beyond myasthenia gravis, the FDA also granted nipocalimab a breakthrough therapy designation for moderate-to-severe Sjögren’s disease, as well as for treating alloimmunized pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn.
Another indication for a breast cancer blockbuster
Developer: AstraZeneca and Daiichi Sankyo
Drug: Enhertu
Why it matters: Enhertu, AstraZeneca and Daiichi Sankyo’s blockbuster HER2-directed antibody-drug conjugate for breast cancer, “changed how cancer is treated,” Ken Keller, CEO and president of Daiichi Sankyo’s U.S. business and head of its global oncology unit, told PharmaVoice earlier this year. Now, Enhertu is poised to potentially add another indication to its label.
In October, the FDA granted Enhertu priority review for patients with HER2-low or HER2-ultralow metastatic breast cancer who have received at least one line of endocrine therapy. The company said it expects a regulatory decision in the first quarter of 2025.
LaFever said all eyes are on Enhertu as the partner companies are “slowly inching their way into total domination.” She believes that this continued drive into new indications could eventually “push them over the edge, right into being the main driver within breast cancer. Perhaps even going over the top of Keytruda at some point.”
That optimistic Enhertu outlook is somewhat tempered by less-than-stellar news about another AstraZeneca-Daiichi Sankyo cancer drug, datopotamab deruxtecan, which the companies withdrew from a previous BLA in non-small cell lung cancer after disappointing trial data, submitting a new one in November.
Datopotamab deruxtecan, dubbed Dato-DXd, is also under review for breast cancer with a Jan. 29 PDUFA date. However, phase 3 results for that drug were disappointing as well.
