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11 views

Documento 666

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Uploaded by

tiyoxeb220
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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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,

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