Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-29 May 2019

News 29/05/2019

EMA’s human medicines committee (CHMP) recommended four medicines for approval at its May 2019 meeting.

The Committee recommended granting a marketing authorisation for Cufence (trientine dihydrochloride), for the treatment of Wilson’s disease, a rare inherited disorder that causes copper to accumulate in the liver, brain and other vital organs. Cufence was designated as an orphan1 medicine during its development.

The CHMP granted a positive opinion for LysaKare (Arginine/lysine) for protecting the kidneys against radiation during radioactive therapy with lutetium (177Lu) oxodotreotide.

Two generic medicines intended for the treatment and prevention of fungal infections received a positive opinion from the Committee: Posaconazole Accord (posaconazole) and Posaconazole AHCL (posaconazole).

Negative opinion on a new medicine

The CHMP adopted a negative opinion recommending the refusal of a marketing authorisation for Xyndari (glutamine). Xyndari was expected to be used to treat sickle cell disease, an inherited form of anemia. For more information please see the question-and-answer document in the grid below.

Negative recommendation on new medicine following re-examination

The applicant for Doxolipad (doxorubicin) requested a re-examination of the Committee's negative opinion adopted at the January 2019 meeting. After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed its previous recommendation to refuse the granting of a marketing authorisation for this medicine, which was intended for the treatment of breast and ovarian cancer.

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

Start of referral

The CHMP started a review of the effectiveness of medicines containing a combination of methocarbamol and paracetamol for the treatment of painful muscle spasms. The review is being carried out at the request of the German medicines agency, BfArM.

For more information, please see the start-of-referral document in the grid below.

Withdrawals of applications

Applications for initial marketing authorisations for Ambrisentan Zentiva (ambrisentan) and Radicava (edaravone) have been withdrawn.

Ambrisentan Zentiva was intended for the treatment of pulmonary arterial hypertension (high blood pressure in the arteries of the lungs).

Radicava was intended for the treatment of amyotrophic lateral sclerosis, a rare disease of the nervous system, where nerve cells in the brain and spinal cord that control voluntary movement gradually deteriorate, causing loss of muscle function and paralysis.

Question-and-answer documents on these withdrawals are available in the grid below.

Agenda and minutes

The agenda of the May 2019 meeting is published on EMA's website. Minutes of the April 2019 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the May 2019 CHMP meeting are represented in the graphic below.

Due to the late finishing of the meeting and EMA’s closure on 30-31 May, further updates may be provided on Monday, 3 June 2019. Please check the CHMP highlights again.


1 As always at time of approval, this orphan designation will now be reviewed by EMA's Committee for Orphan Medicinal Products (COMP) 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: May 2019

Positive recommendations on new medicines

Name of medicineCufence
International non-proprietary name (INN)trientine dihydrochloride 
Marketing-authorisation applicantUnivar BV
Therapeutic indicationTreatment of Wilson's disease
More informationCufence: Pending EC decision

 

Name of medicineLysaKare
INNArginine/lysine
Marketing-authorisation applicantAdvanced Accelerator Applications
Therapeutic indicationProtection of kidneys against radiation during radioactive therapy with lutetium (177Lu) oxodotreotide
More informationLysaKare: Pending EC decision

 

Positive recommendations on new generic medicines

Name of medicinePosaconazole Accord 
INNposaconazole
Marketing-authorisation applicantAccord Healthcare S.L.U.
Therapeutic indicationTreatment and prevention of fungal infections
More informationPosaconazole Accord: Pending EC decision

 

Name of medicinePosaconazole AHCL 
INNposaconazole
Marketing-authorisation applicantAccord Healthcare S.L.U.
Therapeutic indicationTreatment and prevention of fungal infections
More informationPosaconazole AHCL: Pending EC decision

 

Negative recommendation on new medicine

Name of medicineXyndari​
INNglutamine
Marketing-authorisation applicantEmmaus Medical Europe Limited
Therapeutic indicationTreatment of sickle cell disease
More informationXyndari: Pending EC decision

 

Negative recommendation on new medicine following re-examination

Name of medicineDoxolipad
INNdoxorubicin
Marketing-authorisation applicantTLC Biopharmaceuticals B.V.
Therapeutic indicationTreatment of breast and ovarian cancer
More informationDoxolipad: Pending EC decision

 

Start of referral

Name of medicineMethocarbamol/Paracetamol
INNmethocarbamol/paracetamol
More informationMethocarbamol / paracetamol-containing medicinal products

 

Withdrawals of initial marketing authorisation applications

Name of medicineAmbrisentan Zentiva  
INNambrisentan
Marketing-authorisation holderZentiva, k.s.
More informationAmbrisentan Zentiva: Withdrawn application

 

Name of medicineRadicava
INNedaravone
Marketing-authorisation applicantMitsubishi Tanabe Pharma GmbH
More informationRadicava: Withdrawn application

 

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