European Advisory Panel Recommends Two AstraZeneca Drugs For Approval

AstraZeneca Plc (NASDAQ:AZN) and Amgen Inc.'s (NASDAQ:AMGN) Tezspire (tezepelumab) has been recommended for approval in the European Union (EU) for adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the WAYPOINT Phase 3 trial.

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In the WAYPOINT trial, Tezspire demonstrated a statistically significant and clinically meaningful reduction in nasal polyp severity, as measured by the co-primary endpoints: Nasal Polyp Score (NPS) by -2.08 and nasal congestion by -1.04 at week 52 compared to placebo.

Data also showed that Tezspire enabled near-complete elimination of the need for surgery (98%) and significantly reduced the need for systemic corticosteroid treatment (89%) compared to the placebo.

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Regulatory applications are currently under review in the U.S., China, Japan and several other countries based on the WAYPOINT trial.

Tezspire is currently approved for the treatment of severe asthma in the U.S., EU, Japan and more than 60 countries.

Second Drug Receives Recommendation

The CHMP also recommended approving Koselugo (selumetinib) for symptomatic, inoperable plexiform neurofibromas (PN) in adult patients with neurofibromatosis type 1 (NF1).

The positive opinion was based on results from the KOMET Phase 3 trial.

In the primary analysis of the trial, Koselugo showed a statistically significant objective response rate (ORR) of 20% compared to 5% with placebo by cycle 16.

The safety profile of Koselugo in the KOMET Phase 3 trial was consistent with its known profile and established use in paediatric patients.

Koselugo has been recently approved in Japan and other countries for adult patients with NF1 who have symptomatic, inoperable PN based on data from the KOMET Phase 3 trial, and additional regulatory reviews are ongoing.

AZN, AMGN Price Action: AstraZeneca stock is up 1.78% at $77.64 and Amgen is down slightly at $295.28 at publication on Monday.

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