Two new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended two medicines for approval at its July 2021 meeting.

The Committee adopted a positive opinion for Nexviadyme* (avalglucosidase alfa), intended for the treatment of glycogen storage disease type II (Pompe disease).

The CHMP recommended granting a marketing authorisation for the hybrid medicine Imatinib Koanaa (imatinib), intended for the treatment of leukaemia and gastrointestinal stromal tumours. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.

Negative opinion on a new medicine

The CHMP adopted a negative opinion recommending the refusal of a marketing authorisation for Nouryant (istradefylline). Nouryant was intended as a medicine to treat adults with Parkinson’s disease.

For more information on this negative opinion, see the question-and-answer document in the grid below.

Four recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for DeltybaUltomirisVolibris and Vosevi.

Conclusion of referral

The CHMP endorsed findings of a review, which concluded that there is no evidence that Zynteglo causes a blood cancer known as acute myeloid leukaemia (AML).

Re-examination of recommendation on Flynpovi

The applicant for Flynpovi (eflornithine / sulindac) has requested a re-examination of the Committee’s negative opinion for this medicine adopted at its June 2021 meeting. Upon receipt of the grounds of the request, the Agency will re-examine its opinion and issue a final recommendation.

Withdrawal of application

The application to extend the use of Tecentriq (atezolizumab) to include the treatment of early or locally advanced triple-negative breast cancer was withdrawn.

Posted on the EMA website on 23 July 2021