Homepage > Company > Media > Pharma News > 2021 > Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 July 2021 Share

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

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

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).

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of Tecentriq (atezolizumab) to include the treatment of early or locally advanced triple-negative breast cancer was withdrawn.

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.

26/07/2021

https://www.ema.europa.eu/en/

Read also

uniQure Staggers as FDA Questions Data for Huntington’s Gene Therapy Candidate

Agency torpedoes company's plans to submit BLA for gene therapy AMT-130 in Q1 2026.

Kimberly-Clark buys troubled Tylenol-maker Kenvue for $48.7bn

Kimberly-Clark has agreed to acquire Johnson & Johnson (J&J) consumer health spinout Kenvue for $48.7bn.

Femasys gets FDA OK for final FemBloc trial, secures $12M financing, stock surges

Femasys (FEMY) on Monday said that the FDA approved continuation of the final phase of its FemBloc pivotal trial, sending shares 25% higher in premarket trading.

Praxis announces

Praxis announces accelerated development path for relutrigine in SCN2A and SCN8A DEE patients following positive FDA feedback