granted a positive opinion for two informed consent applications for the maintenance treatment of adult patients with moderate to severe chronic obstructive pulmonary disease: CHF 5993 Chiesi Farmaceutici S.
The European Commission will now consider the CHMP
positive opinion, with its decision on the approval expected in April.
It has also been recalled from the market in Canada, CHMP
evaluated Soliris under the European Accelerated Assessment procedure, the fastest evaluation timeframe for full approval awarded by EMEA.
The European Commission, which has the authority to approve medicines for use in the European Union, generally follows the recommendations of the CHMP
and typically renders a final decision within three months of the CHMP
intends to hold a final vote on the treatment indication at their March meeting.
European clinicians provided valuable support to the CHMP
decision and are looking forward to Pharmaxis bringing this new therapeutic treatment option to their patients in the near future," Dr.
The Committee has requested additional data, which could delay the CHMP
opinion until the fourth quarter, but we will be working with the CHMP
in the coming weeks to further clarify their request and the impact on timing".
M2 PHARMA-January 30, 2018-Mylan and Biocon receive positive CHMP
opinion for biosimilar insulin glargine
M2 EQUITYBITES-January 26, 2018-Santhera receives negative CHMP
appeal opinion for Raxone authorisation
recommended granting marketing authorisations for two cancer medicines: Zejula (niraparib), an orphan designated medicine intended for the treatment of ovarian cancer, and Tookad (padeliporfin), for the treatment of adenocarcinoma of the prostate.
opinion recommends that JANUVIA be approved in the European Union for the treatment of type 2 diabetes.