The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued two positive opinions recommending approval of new indications for AstraZeneca and Amgen's biologic Tezspire (tezepelumab) and AstraZeneca and MSD’s Koselugo (selumetinib), marking important advances for patients with challenging chronic and rare diseases.
The CHMP recommended approval of Tezspire as a treatment of adult patients with CRSwNP. Tezspire, a human monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP), is already approved in the EU for severe asthma. The new recommendation highlights its potential role in targeting type 2 inflammatory pathways that drive nasal polyp formation and chronic sinus inflammation, offering patients relief from symptoms such as nasal obstruction, loss of smell, and frequent sinus infections.
Separately, the CHMP recommended approval of Koselugo for the treatment of plexiform neurofibromas (PN) in adult patients with neurofibromatosis type 1 (NF1). Koselugo, an oral selective MEK 1/2 inhibitor, is already authorized in the EU for pediatric patients aged two and older with symptomatic, inoperable PN. Extending its indication to adults addresses an important unmet need for patients facing tumors that can cause pain, functional impairment, and disfigurement, with limited treatment alternatives available.
Both recommendations will now be referred to the European Commission, which grants final EU marketing authorizations. If approved, the new indications for Tezspire and Koselugo would broaden treatment options across distinct therapeutic areas, from chronic airway disease to rare genetic tumors, reinforcing AstraZeneca’s expanding footprint in immunology and oncology.
The dual CHMP opinions underscore ongoing efforts in Europe to accelerate availability of innovative therapies for patients with high disease burdens and few current options.
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