Pharmaceutical Market Europe • December 2025 • 7
NEWS
Regeneron’s Libtayo receives EC approval for skin cancer
Regeneron’s Libtayo (cemiplimab) has received approval from the European Commission (EC) for the adjuvant treatment of cutaneous squamous cell carcinoma (CSCC) with high risk of recurrence after surgery and radiation.
A phase 3 trial showed that Libtayo was the first immunotherapy to significantly improve disease-free CSCC survival in the adjuvant setting. When tested in patients with a high risk of cancer recurrence following surgical or radiological treatments, it was shown to reduce the risk of disease recurrence or death by 68% compared to placebo.
CSCC, a form of non-melanoma skin cancer (NMSC), is one of the most common cancers in the world. The incidence of NMSC in the EU is projected to increase by 40% in the coming decades. While CSCC can often be treated successfully through surgery or radiation, some patients face a high-risk, recurring form of the cancer.
Libtayo’s safety profile as an adjuvant treatment for CSCC is consistent with its safety profile as a monotherapy for the treatment of other cancers. This is the sixth approval for Libtayo in the EU.
J&J’s Tremfya improves symptoms of psoriatic arthritis
Johnson & Johnson (J&J) has announced new data showing that Tremfya (guselkumab) reduces symptoms of psoriatic arthritis (PsA) and also inhibits structural joint damage associated with the condition.
J&J’s phase 3 APEX study showed that Tremfya continued to inhibit joint damage up to and throughout week 48 of the study. Participants also showed a clinically meaningful improvement in the American College of Rheumatology’s response criteria rates, which measure tenderness and swelling in affected joints. No new safety signals associated with Tremfya were demonstrated in the study, in line with the drug’s well-established safety profile.
J&J recently submitted a Biologics License Application to the US FDA for approval to edit the Tremfya label, adding new evidence for its capacity to inhibit the progression of joint damage.
PsA is a long-term inflammatory arthritis condition characterised by symptoms such as pain, swelling and stiffness in the joints, as well as fatigue and possible flare-ups of psoriasis-related skin symptoms. The condition can be severely disabling, and early intervention is important for the prevention of joint damage.
Merck gets FDA Fast Track for generalised myasthenia gravis drug
Merck has received US FDA Fast Track designation for its generalised myasthenia gravis (gMG) drug treatment. Current treatments for gMG have limited efficacy and Merck’s cladribine capsules could become the first oral treatment for gMG, if approved.
gMG is a rare autoimmune neuromuscular disorder characterised by severe muscle weakness. It can affect any part of the body, but often presents in the voluntary muscles that control the eyes, eyelids, face and mouth. It can cause difficult moving, chewing, swallowing and occasionally even breathing.
Cladribine is designed to selectively target the B and T cells, which are believed to contribute to the production of harmful autoantibodies, causing inflammation and damage to the neuromuscular junction. The cladribine capsules are currently being studied in the global phase 3 MyClad trial. As part of the MyClad trial, Merck worked with gMG patient advocacy groups worldwide.
The FDA also granted Orphan Drug designation to the cladribine capsules in June 2023, a special status granted to drugs that treat very rare diseases. Merck will announce results from the MyClad trial following its completion.
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