EMA Recommends Eleven New Medicines

The European Medicines Agency (EMA) announced on July 22, 2022 that its Committee for Medicinal Products for Human Use (CHMP) recommended approval for 11 medicines at its July 2022 meeting. The medicines treat a variety of conditions including cancer and type 2 diabetes.

The approved medicines included the following:

• Celdoxome pegylated liposomal (doxorubicin hydrochloride) was approved for the treatment of metastatic breast cancer, advanced ovarian cancer, progressive multiple myeloma, and Kaposi's sarcoma.

• Lupkynis (voclosporin) was approved to treat lupus nephritis, which is a condition caused by lupus where the kidneys are inflamed.
• Mounjaro (tirzepatide) was approved for the treatment of adults with type 2 diabetes mellitus.
• Opdualag (relatlimab/nivolumab) was approved to treat melanoma that has spread to other parts of the body and cannot be removed by surgery.
• Tezspire (Tezepelumab) was approved as an add-on treatment in adult and adolescent patients with severe asthma.
• Vabysmo (faricimab) was approved for the treatment of neovascular age-related macular degeneration and visual impairment due to diabetic macular edema in adults.
• Thalidomide Lipomed (thalidomide) received a positive opinion for the treatment of multiple myeloma.

The CHMP also granted conditional marketing authorization for Tecvayli (teclistamab) for the treatment of adults with relapsed and refractory multiple myeloma, who have received at least three prior therapies. Tecvayli was processed through EMA’s PRIority MEdicines scheme, which provides early scientific and regulatory support for drugs that treat unmet needs.

Source: EMA