EU drug regulator to review Lilly’s Mounjaro in multi-dose pen

By Thomson Reuters Feb 19, 2024 | 8:09 AM

By Ludwig Burger

FRANKFURT (Reuters) – The European Union’s healthcare regulator will this week review the use of Eli Lilly’s approved Mounjaro drug against diabetes and obesity when prefilled in a multi-dose injection pen, according to a meeting agenda posted on the watchdog’s website on Monday.

The U.S. drugmaker won EU approval for the weekly injection late last year and has initially made starter doses available in member states Germany and Poland packaged in vials, so that patients need to draw the medication into syringes before injection.

Lilly’s “Kwikpen”, a multi-dose injection device that is good for four weekly subcutaneous shots, will be considered as a new route of administration for Mounjaro in a meeting of an expert panel of the European Medicines agency, according to the agenda.

Lilly has previously said European approval of the pen injector could come by the middle of the year.

Britain last week became the first major market where Mounjaro was launched in the four-week Kwikpen.

(Reporting by Ludwig Burger; Editing by David Goodman, Kirsten Donovan)