Home » EMA Backs Acalabrutinib for Orphan Status in 3 Indications
EMA Backs Acalabrutinib for Orphan Status in 3 Indications
The European Medicines Agency has endorsed Acerta’s acalabrutinib for orphan drug status for the treatment of chronic lymphocytic leukemia, mantle cell lymphoma and lymphoplasmacytic lymphoma. The drug is a BTK inhibitor in Phase 2/3 trials for all three indications.
AstraZeneca purchased a majority stake in Acerta for $4 billion in December, and analysts viewed the orphan announcement as an endorsement of AZ’s decision to invest in the company.
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