Five new meds backed for approval by CHMP

The European Medicines Agency’s human medicines committee (CHMP) recommended new five medicines for approval at its November 2020 meeting.bBased on these recommendations, a final decision regarding approval is expected from the European Commission in the next two to three months.

The Committee recommended granting a marketing authorization for Swiss pharma giant Roche’s (ROG: SIX) Phesgo (pertuzumab/trastuzumab) for the treatment of early and metastatic breast cancer. The recommendation from the CHMP is based on results from the pivotal Phase III FeDeriCa study, which showed that treatment with Phesgo produced non-inferior levels of Perjeta and Herceptin in the blood when compared to IV administration of the two medicines. The safety profile of Phesgo with chemotherapy was comparable to IV administration of Perjeta plus Herceptin and chemotherapy, and no new safety signals were identified, including no meaningful difference in cardiac toxicity. The most common adverse events in both arms were alopecia, nausea, diarrhoea and anemia.

The CHMP adopted a positive opinion for Roclanda (latanoprost/netarsudil), from US ophthalmic drugs specialist Aerie Pharmaceuticals (Nasdaq: AERI), for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction.