Bumper crop of novel meds backed for approval by EMA's CHMP
The European Medicines Agency’s human medicines committee (CHMP) has recommended eight novel medicines for approval at its December 2020 meeting, as well as two biosimilars. The European Commission (EC) will now review the CHMP recommendation and a final decision on the Marketing Authorizations in the European Union is expected within two or three months.
The Committee recommended granting a conditional marketing authorization for Daiichi Sankyo (TYO: 4568) and AstraZeneca's (LSE: AZN) Enhertu (trastuzumab deruxtecan) for the treatment of metastatic HER2-positive breast cancer. Enhertu was reviewed under EMA’s accelerated assessment program.
The CHMP adopted a positive opinion for Heplisav B (hepatitis B surface antigen), from Dynavax Technologies (Nasdaq: DVAX), for the active immunization against hepatitis B virus infection.
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