EU Decision Time For Teclistamab & Seven Other Drugs; Incyte Withdraws Parsaclisib Filing

Janssen’s bispecific antibody, teclistamab, and Eli Lilly’s potential blockbuster diabetes drug, tirzepatide, are among the products that are this week up for an opinion by the European Medicines Agency on whether they should be approved in the EU.

Question marks background. High resolution 3d render
Companies may soon learn if their drugs will be recommended for EU approval • Source: Alamy

 The European Medicines Agency is this week set to decide whether to recommend pan-EU marketing authorization for eight new products including teclistamab, Janssen Pharmaceutical’s investigational orphan drug for treating relapsed or refractory multiple myeloma (RRMM).

Teclistamab is an off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 that during its development...

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