EMA专家委员会本周建议批准Icotyde等12款新药及8项适应症扩展

An expert panel of the EU drug regulator, the European Medicines Agency, endorsed 12 new medicines and eight label expansions for approval this week, including products from U.S. drugmakers such as Johnson & Johnson (JNJ) and Gilead (GILD).
The New Jersey-based healthcare giant received a positive opinion from the EMA's Committee for Medicinal Products for Human Use for its new plaque psoriasis pill, Icotyde, developed with Protagonist Therapeutics (PTGX). Subject to a final decision on authorization from the European Commission, the once-daily oral therapy will therefore be available in Europe for people aged 12 years and older with the inflammatory skin condition.
The California-based drugmaker announced a positive CHMP opinion for a label expansion of its antibody drug conjugate Trodelvy in combination with Merck’s (MRK) anti-PD-1 therapy Keytruda as a first-line option for adults with unresectable triple-negative breast cancer.
If finalized by the EC, Gilead (GILD) stands to receive a second EU approval for Trodelvy in a first-line setting for breast cancer. The treatment is already available as a single agent for adults with TNBC who have not undergone systemic therapy and are not eligible for PD-1 or PD-L1 inhibitors.
The Swiss drugmaker announced a positive CHMP opinion for its eye therapy Susvimo to treat neovascular age-related macular degeneration, a leading cause of blindness among people older than 60.
The CHMP also issued a positive opinion on Zokovea, an antiviral therapy developed by the Japanese drugmaker Shionogi (SGIOY) (SGIOF) for the post-exposure prophylaxis of COVID-19.
The Anglo-Swedish drugmaker announced on Friday a positive CHMP opinion for a label expansion of its asthma therapy Trixeo Aerosphere. Specifically, the CHMP has recommended EU approval of the inhaler as a late-line option for maintenance treatment for asthma in people aged 12 years and older.
If finalized by the EC, the decision will pave the way for Astra (AZN) to market the drug for the second indication in Europe. Trixeo Aerosphere is already available in the region for adults with chronic obstructive pulmonary disease.
The company also announced a positive CHMP opinion calling for a label expansion for its antibody-drug conjugate Enhertu, developed with Daiichi Sankyo (DSKYF) (DSNKY), as a first-line therapy for breast cancer.
The committee recommended the use of Enhertu with pertuzumab, an anticancer agent marketed by Roche (RHHBY) for first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. The drug is already available in the EU for a range of tumor indications, including lung and gastric cancers.
Amgen’s (AMGN) Repatha, AbbVie’s (ABBV) Rinvoq, Novartis’ (NVS) Piqray, and Bayer’s (BAYRY) (BAYZF) Piqray were among other medicines recommended for EU label expansions by the CHMP this week.