Pharmaceutical Technology

CHMP recommends European authorisation for seven new drugs

Pfizer’s Elrexfio and Astellas’ Veozah are among the seven drugs recommended for approval by the European regulatory committee.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended seven new drugs for authorisation.

The drugs include Pfizer’s Elrexfio for the treatment of multiple myeloma and Astellas Pharma’s Veozah for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Elrexfio (elranatamab) is a subcutaneously administered bispecific B-cell maturation antigen-directed CD3 T-cell engager. The US Food and Drug Administration (FDA) granted accelerated approval for Elrexfio in August for patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

According to GlobalData, sales for Elrexfio are expected to reach $536m by 2029. One of its competitors in the market is Talvey (talquetamab-tgvs), marketed by Janssen, which was approved as a fifth-line treatment for relapsed/refractory multiple myeloma in August. Talvey is forecasted to generate $1.9bn in sales by 2029.

GlobalData is the parent company of Pharmaceutical Technology.

Astellas Pharma’s Veozah is a non-hormonal treatment to reduce moderate to severe VMS associated with menopause. Veozah works by blocking neurokinin B binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neurone, reducing hot flashes and night sweats by restoring balance in the hypothalamus, which controls temperature.

The FDA approved Veozah in May 2023, and sales are expected to reach $2.5bn by 2029. According to Astellas’ Q1 FY2023 financial report, Q1 sales of Veozah were limited, with JPY6m ($40,000), however, Astellas expects sales to reach JPY49.3bn ($3.3bn) as per its full-year forecast.

Among the recommended drugs are Santhera Pharmaceuticals’ Agamree (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD), Geurbet’s Elucirem (gadopiclenol) and Bracco Imaging’s Vueway (gadopiclenol), both used for MRI diagnostics.

The list also includes Immedica Pharma’s Loargys (pegzilarginase) for the treatment of hyperargininaemia, and Rezzayo (rezafungin), marketed by Mundipharma for the treatment of invasive candidiasis.