Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 July 2021

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 Deltyba, Ultomiris, Volibris 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).

For more information, see the public health communication in the grid below.

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of Tecentriq (atezolizumab) to include the treatment of early or locally advanced triple-negative breast cancer was withdrawn.

A question-and-answer document on the withdrawal is available in the grid below.

Agenda and minutes

The agenda of the July 2021 CHMP meeting is published on EMA's website. Minutes of the June 2021 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the July 2021 CHMP meeting are represented in the graphic below.

*This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.