AstraZeneca Drugs Win Key EU Panel Recommendation
Tezspire and Koselugo recommended for approval, paving the way for new treatment options in the European Union.
AstraZeneca Plc (AZN) has received a significant boost as a European advisory panel recommended two of its drugs, Tezspire and Koselugo, for approval. The positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is a critical step towards full marketing authorization in the European Union for new indications for both treatments.
Tezspire, which AstraZeneca developed in partnership with Amgen, was recommended for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP). This recommendation is based on the positive results from the WAYPOINT Phase 3 trial, which demonstrated a significant reduction in the severity of nasal polyps and congestion. The a near-elimination of the need for surgery for these patients, a significant advancement in treatment.
Koselugo, a drug co-developed and co-commercialized with Merck & Co, received a positive recommendation for the treatment of adult patients with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas. This recommendation was supported by data from the KOMET Phase 3 trial. If approved, Koselugo would be the for adults with this condition in the EU, addressing a significant unmet medical need.
The market has reacted positively to the news, with following the announcement. The recommendations for Tezspire and Koselugo represent a potential expansion of AstraZeneca's market reach and underscore the company's commitment to developing treatments for rare and debilitating diseases. The final approval decision now rests with the European Commission, which typically follows the CHMP's recommendations within 67 days. These positive developments are a testament to AstraZeneca's robust pipeline and its ability to bring innovative medicines to patients in need, with in the U.S., China, and Japan.