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

News 23/07/2021

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of Tecentriq (atezolizumab) to include the treatment of early or locally advanced triple-negative breast cancer was withdrawn.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


CHMP statistics: July 2021

Positive recommendation on new medicine

Name of medicineNexviadyme
INNavalglucosidase alfa
Marketing-authorisation applicantGenzyme Europe BV
Therapeutic indicationTreatment of glycogen storage disease type II (Pompe disease)
More informationNexviadyme: Pending EC decision

Positive recommendation on new hybrid medicine

Name of medicineImatinib Koanaa
Marketing-authorisation applicantKOANAA Healthcare GmbH
Therapeutic indicationTreatment of leukaemia and gastrointestinal stromal tumours
More informationImatinib Koanaa: Pending EC decision


Negative recommendation on new medicine

Name of medicineNouryant
Marketing-authorisation applicantKyowa Kirin Holdings B.V.
Therapeutic indicationTreatment of Parkinson’s disease
More informationNouryant: Questions and answers


Positive recommendations on extensions of indications

Name of medicineDeltyba
Marketing-authorisation holderOtsuka Novel Products GmbH
More informationDeltyba: Pending EC decision


Name of medicineUltomiris
Marketing-authorisation holderAlexion Europe SAS
More informationUltomiris: Pending EC decision


Name of medicineVolibris
Marketing-authorisation holderGlaxoSmithKline (Ireland) Limited
More informationVolibris: Pending EC decision


Name of medicineVosevi
INNsofosbuvir / velpatasvir / voxilaprevir
Marketing-authorisation holderGilead Sciences Ireland UC
More informationVosevi: Pending EC decision


Conclusion of referral

Name of medicineZynteglo
INNbetibeglogene autotemcel
More informationCHMP endorses review finding no link between viral vector in Zynteglo and blood cancer

Withdrawal of post-authorisation marketing application

Name of medicineTecentriq
Marketing-authorisation applicantRoche Registration GmbH
More information

Tecentriq: Questions and answers

Re-examination of recommendation for new medicine

Name of medicineFlynpovi
INNeflornithine / sulindac
Marketing-authorisation applicantCancer Prevention Pharma (Ireland) Limited
More informationFlynpovi: Questions and answers

Other opinions

Name of medicineSiklos
Marketing-authorisation holderAddmedica S.A.S.
More informationSiklos: Questions and answers


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