New MHRA authorizes Dupixent for COPD
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Sanofi’s (Euronext: SAN) mega blockbuster drug Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils.
Specifically, says the French pharma major, the approval covers patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.
According to Sanofi, Dupilumab, which generated sales of 3.3 billion euros ($4.3 billion) in the second quarter of this year, is the first-ever targeted biologic for people with uncontrolled COPD in the UK. The National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC) will now review dupilumab for reimbursement.
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