CHMP Recommends 14 Medicines for Approval at July Meeting

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At its meeting held July 22–25, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave positive opinions or granted marketing authorizations to 14 medicines, EMA said in a press release issued July 26 (1).

One negative opinion was given for a drug for the intended treatment of Alzheimer’s disease; 11 others received extensions of their various therapeutic indications.

Anzupgo (delgocitinib), which treats moderate to severe chronic hand eczema in adults for who topical corticosteroids were ineffective, was granted a marketing authorization. So too were Vyloy (zolbetuximab), treating a form of stomach cancer known as gastric or gastroesophageal junction adenocarcinoma, and Iqirvo (elafibranor), given a conditional authorization for the treatment of primary biliary cholangitis, which is a chronic, progressive autoimmune disease that can cause liver damage, according to CHMP (1).

Additionally, the following three were given positive opinions:

• Kayfanda (odevixibat) was issued a positive opinion under exceptional circumstances, for treatment of cholestatic pruritis in patients with Alagille syndrome—a rare and life-threatening genetic disorder with numerous clinical manifestations
• Loqtorzi (toripalimab), for treating nasopharyngeal and esophageal squamous cell carcinomas
• Vevizye (ciclosporin), which treats adult patients with moderate to severe dry eye disease that has not improved with treatment with tear substitutes (1).

Johnson & Johnson was one of the first companies to respond to the CHMP announcement, as its Yuvanci (macitentan/tadalafil) was given a positive opinion for treatment of pulmonary arterial hypertension (PAH) (2).

“PAH is a devastating disease affecting people of all ages and the burden the condition places on the daily lives of people living with it should not be underestimated,” Tamara Werner-Kiechle, MD, of Johnson & Johnson Innovative Medicine, said in a press release.

Six biosimilar medicines received positive opinions: Eksunbi, Fymskina, and Otulfi (all ustekinumab), for treatment of plaque psoriasis (both adult and pediatric), psoriatic arthritis, ulcerative colitis, and Crohn’s disease; Ituxredi (rituximab), for treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis; Ranibizumab Midas (ranibizumab), for treatment of neovascular or “wet” age-related macular degeneration and other visual impairment issues; and Tuznue (trastuzumab), for treatment of breast and gastric cancers (1).

Extensions of therapeutic indications were given to Arexvy, Braftovi, Edurant, Keytruda, Mektovi, Opsumit, Padcev, Rybrevant, Slenyto, Spevigo and Tecentriq (1).

The negative opinion was given to Leqembi (lecanemab), which is intended to treat Alzheimer’s disease. CHMP did not grant a marketing authorization for Leqembi because it did not consider the effects of the drug in delaying cognitive decline to outweigh the risk of serious side effects, including frequent amyloid-related imaging abnormalities, which may involve swelling and potential bleeding in the brain (1).

References

1. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 22–25 July 2024. Press Release. July 26, 2024.
2. Janssen-Cilag International NV. Johnson & Johnson Receives Positive CHMP Opinion for Yuvanci (Single Tablet Combination Therapy [STCT] of Macitentan and Tadalafil) for Treatment of Patients with Pulmonary Arterial Hypertension (PAH). Press Release. July 26, 2024.