CHMP Recommends New Medicines and Indication Expansions

At its meeting from July 22-25, 2024, the Committee for Medicinal Products for Human Use (CHMP) recommended 14 new medicines for approval and advised the extension of indications for 11 existing medicines.

New Medicine Approvals

Among the new medicines recommended for marketing authorization, Anzupgo (delgocitinib) was suggested for treating moderate to severe chronic hand eczema in adults who have not responded adequately to topical corticosteroids. The committee also supported a conditional marketing authorization for Iqirvo (elafibranor) for managing primary biliary cholangitis, a chronic autoimmune liver disease.

Kayfanda (odevixibat) received a positive opinion under exceptional circumstances for treating cholestatic pruritus in patients with Alagille syndrome, a rare genetic disorder with multi-organ involvement. Loqtorzi (toripalimab) was endorsed for treating nasopharyngeal carcinoma and oesophageal squamous cell carcinoma.

For severe dry eye disease unresponsive to tear substitutes, Vevizye (ciclosporin) was recommended. Vyloy (zolbetuximab) was suggested for gastric or gastro-oesophageal junction adenocarcinoma. Additionally, Yuvanci (macitentan/tadalafil) was supported for treating pulmonary arterial hypertension.

Biosimilars and Generics

The CHMP also adopted positive opinions for six biosimilars:

• Eksunbi (ustekinumab) and Fymskina (ustekinumab) for various conditions including plaque psoriasis and Crohn’s disease.
• Ituxredi (rituximab) for multiple indications such as non-Hodgkin’s lymphoma and rheumatoid arthritis.
• Otulfi (ustekinumab) for plaque psoriasis and Crohn’s disease.
• Ranibizumab Midas (ranibizumab) for age-related macular degeneration and other retinal conditions.
• Tuznue (trastuzumab) for breast and gastric cancer.

Finally, the committee recommended granting marketing authorization for Axitinib Accord (axitinib), a generic for advanced renal cell carcinoma.

Highlights

• CHMP recommended 14 new medicines for approval.
• Anzupgo and Iqirvo are highlighted for eczema and liver disease treatments.
• Kayfanda and Loqtorzi address rare genetic disorders and cancer, respectively.
• Vevizye and Vyloy target severe dry eye disease and stomach cancer.
• Six biosimilars and one generic medicine received positive opinions.

Data Source: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-july-2024