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AZN Gets CHMP Nod for Label Expansion of Koselugo & Tezspire
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Key Takeaways
CHMP recommended AZN's Koselugo for adult NF1 patients with inoperable plexiform neurofibromas.
Recommendation was backed by the phase III KOMET study showing improved response rates with Koselugo.
CHMP recommended Tezspire for the treatment of adult patients with CRSwNP in the EU.
AstraZeneca (AZN - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has recommended approval of its oral, selective MEK inhibitor, Koselugo (selumetinib), for expanded use.
The CHMP has now recommended the approval of Koselugo for treating symptomatic, inoperable plexiform neurofibromas (PN) in adult patients with neurofibromatosis type 1 (NF1), a rare genetic disorder, in the European Union (“EU”).
The positive CHMP opinion was backed by data from the global phase III KOMET study, which evaluated Koselugo in adult patients with NF1 who have symptomatic, inoperable PN. In the primary analysis of the KOMET study, treatment with Koselugo demonstrated a statistically significant objective response rate of 20% versus 5% with placebo by cycle 16.
Koselugo is currently approved for the treatment of certain pediatric patients with NF1 who have symptomatic, inoperable PN, in the United States, the EU, Japan, China and other countries.
Koselugo was recently approved for treating adult patients with NF1 who have symptomatic, inoperable PN in Japan and some other countries.
AstraZeneca also has a profit-sharing deal with Merck (MRK - Free Report) for Koselugo. Apart from Koselugo, the Merck-AstraZeneca deal also includes Lynparza.
AZN’s Price Performance
Year to date, shares of AstraZeneca have rallied 18.2%, compared with the industry’s rise of 3.5%.
Image Source: Zacks Investment Research
AZN Gets CHMP Nod for Tezspire
The CHMP has also recommended approval of AstraZeneca and Amgen’s (AMGN - Free Report) Tezspire (tezepelumab) for the treatment of adult patients with chronic rhinosinusitis with nasal polyps, a chronic inflammatory condition, in the EU.
This positive CHMP opinion was based on data from the phase III WAYPOINT study, which evaluated Tezspire for the given indication. Data from the same showed that treatment with Tezspire led to a statistically significant and clinically meaningful reduction in nasal polyp severity and nasal congestion versus placebo at week 52. Treatment with Tezspire also nearly eliminated the need for surgery and significantly reduced systemic corticosteroid use as compared to placebo.
Tezspire is currently approved in the United States, the EU, Japan and several other countries for severe asthma.
A regulatory filing seeking approval of Tezspire for treating CRSwNP is currently under review in the United States. A final decision from the FDA is expected on Oct. 19, 2025.
Tezspire is also being evaluated in late-stage studies for treating eosinophilic esophagitis and chronic obstructive pulmonary disease.
Amgen records Tezspire product sales in the United States while AstraZeneca records its share of U.S. gross profits as Alliance revenues. AZN books product sales in markets outside the United States.
Image: Bigstock
AZN Gets CHMP Nod for Label Expansion of Koselugo & Tezspire
Key Takeaways
AstraZeneca (AZN - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has recommended approval of its oral, selective MEK inhibitor, Koselugo (selumetinib), for expanded use.
The CHMP has now recommended the approval of Koselugo for treating symptomatic, inoperable plexiform neurofibromas (PN) in adult patients with neurofibromatosis type 1 (NF1), a rare genetic disorder, in the European Union (“EU”).
The positive CHMP opinion was backed by data from the global phase III KOMET study, which evaluated Koselugo in adult patients with NF1 who have symptomatic, inoperable PN. In the primary analysis of the KOMET study, treatment with Koselugo demonstrated a statistically significant objective response rate of 20% versus 5% with placebo by cycle 16.
Koselugo is currently approved for the treatment of certain pediatric patients with NF1 who have symptomatic, inoperable PN, in the United States, the EU, Japan, China and other countries.
Koselugo was recently approved for treating adult patients with NF1 who have symptomatic, inoperable PN in Japan and some other countries.
AstraZeneca also has a profit-sharing deal with Merck (MRK - Free Report) for Koselugo. Apart from Koselugo, the Merck-AstraZeneca deal also includes Lynparza.
AZN’s Price Performance
Year to date, shares of AstraZeneca have rallied 18.2%, compared with the industry’s rise of 3.5%.
Image Source: Zacks Investment Research
AZN Gets CHMP Nod for Tezspire
The CHMP has also recommended approval of AstraZeneca and Amgen’s (AMGN - Free Report) Tezspire (tezepelumab) for the treatment of adult patients with chronic rhinosinusitis with nasal polyps, a chronic inflammatory condition, in the EU.
This positive CHMP opinion was based on data from the phase III WAYPOINT study, which evaluated Tezspire for the given indication. Data from the same showed that treatment with Tezspire led to a statistically significant and clinically meaningful reduction in nasal polyp severity and nasal congestion versus placebo at week 52. Treatment with Tezspire also nearly eliminated the need for surgery and significantly reduced systemic corticosteroid use as compared to placebo.
Tezspire is currently approved in the United States, the EU, Japan and several other countries for severe asthma.
A regulatory filing seeking approval of Tezspire for treating CRSwNP is currently under review in the United States. A final decision from the FDA is expected on Oct. 19, 2025.
Tezspire is also being evaluated in late-stage studies for treating eosinophilic esophagitis and chronic obstructive pulmonary disease.
Amgen records Tezspire product sales in the United States while AstraZeneca records its share of U.S. gross profits as Alliance revenues. AZN books product sales in markets outside the United States.
AZN's Zacks Rank
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.