Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-29 May 2019
News
Human
Medicines
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for initial marketing authorisations for Ambrisentan Zentiva (ambrisentan) and Radicava (edaravone) have been withdrawn.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.
Positive recommendations on new medicines
| Name of medicine | Cufence |
| International non-proprietary name (INN) | trientine dihydrochloride |
| Marketing-authorisation applicant | Univar BV |
| Therapeutic indication | Treatment of Wilson's disease |
| More information | Cufence: Pending EC decision |
| Name of medicine | LysaKare |
| INN | Arginine/lysine |
| Marketing-authorisation applicant | Advanced Accelerator Applications |
| Therapeutic indication | Protection of kidneys against radiation during radioactive therapy with lutetium (177Lu) oxodotreotide |
| More information | LysaKare: Pending EC decision |
Positive recommendations on new generic medicines
| Name of medicine | Posaconazole Accord |
| INN | posaconazole |
| Marketing-authorisation applicant | Accord Healthcare S.L.U. |
| Therapeutic indication | Treatment and prevention of fungal infections |
| More information | Posaconazole Accord: Pending EC decision |
| Name of medicine | Posaconazole AHCL |
| INN | posaconazole |
| Marketing-authorisation applicant | Accord Healthcare S.L.U. |
| Therapeutic indication | Treatment and prevention of fungal infections |
| More information | Posaconazole AHCL: Pending EC decision |
Negative recommendation on new medicine
| Name of medicine | Xyndari? |
| INN | glutamine |
| Marketing-authorisation applicant | Emmaus Medical Europe Limited |
| Therapeutic indication | Treatment of sickle cell disease |
| More information | Xyndari: Pending EC decision |
Negative recommendation on new medicine following re-examination
| Name of medicine | Doxolipad |
| INN | doxorubicin |
| Marketing-authorisation applicant | TLC Biopharmaceuticals B.V. |
| Therapeutic indication | Treatment of breast and ovarian cancer |
| More information | Doxolipad: Pending EC decision |
Start of referral
| Name of medicine | Methocarbamol/Paracetamol |
| INN | methocarbamol/paracetamol |
| More information | Methocarbamol / paracetamol-containing medicinal products |
| Name of medicine | Ambrisentan Zentiva |
| INN | ambrisentan |
| Marketing-authorisation holder | Zentiva, k.s. |
| More information | Ambrisentan Zentiva: Withdrawn application |
| Name of medicine | Radicava |
| INN | edaravone |
| Marketing-authorisation applicant | Mitsubishi Tanabe Pharma GmbH |
| More information | Radicava: Withdrawn application |