Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018
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EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2018 meeting.
Two orphan medicines1 received a positive opinion from the Committee: Besremi (ropeginterferon alfa-2b), for the treatment of polycythaemia vera without symptomatic splenomegaly, and Trecondi (treosulfan), for the conditioning treatment prior to allogeneic haematopoietic stem cell transplantation.
The CHMP recommended granting a marketing authorisation for Lusutrombopag Shionogi (lusutrombopag), for the treatment of severe thrombocytopenia in adults with chronic liver disease undergoing invasive procedures.
Rizmoic (naldemedine) received a positive opinion for the treatment of opioid-induced constipation.
The Committee granted a positive opinion for Tobramycin PARI (tobramycin), a hybrid medicine for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged six years and older with cystic fibrosis. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of a reference product and in part on new data.
The biosimilar medicine Zirabev (bevacizumab) received a positive opinion for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer and carcinoma of the cervix.
The Committee recommended for approval the generic medicine Miglustat Dipharma (miglustat), for the treatment of adult patients with mild to moderate type 1 Gaucher disease.
Six recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Adcetris, Rapiscan, Rubraca, Simponi, Sprycel and Trimbow.
Start of referral
The CHMP started a review of medicines containing the antibiotic fosfomycin, which is used in a number of EU Member States to treat a range of bacterial infections. The Committee will re-evaluate the uses and doses authorised in the light of up-to-date knowledge on antibacterial therapy. For more information, please see the start-of-referral document in the grid below.
Outcome of review on metamizole-containing medicines
The CHMP recommended that the maximum daily dose of the painkiller metamizole and the contraindications to its use in pregnancy or in women who are breastfeeding should be harmonised for all products on the EU market. Metamizole medicines are marketed in many EU Member States to treat severe pain and fever that cannot be controlled with other treatments. For more information, please see the public health recommendation in the grid below.
Outcome of review on omega-3 fatty acid medicines
The CHMP concluded that omega-3 fatty acid medicines are not effective in preventing further heart and blood vessels problems in patients who have had a heart attack. The conclusion, based on a review of data accumulated over the years, means that these medicines will no longer be authorised for such use. For more information, please see the public health recommendation in the grid below.
Status of review of impurities in sartan medicines
The review of the blood pressure medicines containing candesartan, irbesartan, losartan, olmesartan or valsartan in relation to impurities found in some batches is still ongoing. A new timetable for the finalisation of the review will be published shortly.
Withdrawals of applications
Applications for initial marketing authorisations for Fyzoclad (adalimumab) and canakinumabNovartis (canakinumab) have been withdrawn. Fyzoclad was intended to be used to treat a number of inflammatory diseases. Canakinumab Novartis was intended to be used to prevent serious events such as stroke, heart attack or death in patients who have had a heart attack.
Question-and-answer documents on these withdrawals are available in the grid below.
Agenda and minutes
The agenda of the December 2018 meeting is published on EMA's website. Minutes of the November 2018 CHMP meeting will be published in the coming weeks.
1 As always at time of approval, these orphan designations will now be reviewed by EMA's Committee for Orphan Medicinal Products (COMP) to determine whether the information available to date allows maintaining the medicines’ orphan status and granting the medicines ten years of market exclusivity.
CHMP statistics
Key figures from the December 2018 CHMP meeting are represented in the graphic below.
Positive recommendations on new medicines
| Name of medicine | Besremi |
|---|---|
| International non-proprietary name (INN) | ropeginterferon alfa-2b |
| Marketing-authorisation applicant | AOP Orphan Pharmaceuticals AG |
| Therapeutic indication | Treatment of polycythaemia vera without symptomatic splenomegaly. |
| Name of medicine | Lusutrombopag Shionogi |
|---|---|
| INN | lusutrombopag |
| Marketing-authorisation applicant | Shionogi B.V. |
| Therapeutic indication | Treatment of severe thrombocytopenia in adults with chronic liver disease undergoing invasive procedures. |
| Name of medicine | Rizmoic |
|---|---|
| INN | naldemedine |
| Marketing-authorisation applicant | Shionogi B.V. |
| Therapeutic indication | Treatment of opioid-induced constipation. |
| Name of medicine | Trecondi |
|---|---|
| INN | treosulfan |
| Marketing-authorisation applicant | medac Gesellschaft fur klinische Spezialpraparate mbH |
| Therapeutic indication | Conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) |
Positive recommendation on new hybrid medicine
| Name of medicine | Tobramycin PARI |
|---|---|
| INN | tobramycin |
| Marketing-authorisation applicant | PARI Pharma Gmb |
| Therapeutic indication | Management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis. |
Positive recommendation on new biosimilar medicine
| Name of medicine | Zirabev |
|---|---|
| INN | bevacizumab |
| Marketing-authorisation applicant | Pfizer Europe MA EEIG |
| Therapeutic indication | Treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer and carcinoma of the cervix. |
Positive recommendations on new generic medicine
| Name of medicine | Miglustat Dipharma |
|---|---|
| INN | miglustat |
| Marketing-authorisation applicant | Dipharma B.V. |
| Therapeutic indication | Treatment of adult patients with mild to moderate type 1 Gaucher disease. |
Positive recommendations on extensions of indications
| Name of medicine | Adcetris |
|---|---|
| INN | brentuximab vedotin |
| Marketing-authorisation holder | Takeda Pharma A/S |
| Name of medicine | Rapiscan |
|---|---|
| INN | regadenoson |
| Marketing-authorisation holder | GE Healthcare AS |
| Name of medicine | Rubraca |
|---|---|
| INN | rucaparib |
| Marketing-authorisation holder | Clovis Oncology UK Limited |
| Name of medicine | Simponi |
|---|---|
| INN | golimumab |
| Marketing-authorisation holder | Janssen Biologics B.V. |
| Name of medicine | Sprycel |
|---|---|
| INN | dasatinib |
| Marketing-authorisation holder | Bristol-Myers Squibb Pharma EEIG |
| Name of medicine | Trimbow |
|---|---|
| INN | beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium |
| Marketing-authorisation holder | Chiesi Farmaceutici S.p.A. |
Start of referral
| Name of medicine | Fosfomycin containing medicinal products |
|---|---|
| INN | fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol |
| More information | EMA begins review of medicines containing fosfomycin |
Public-health recommendations
| Name of medicine | Metamizole containing medicinal products |
|---|---|
| INN | metamizole |
| More information | EMA recommends aligning doses of metamizole medicines and their use during pregnancy and breastfeeding |
| Name of medicine | Omega-3 fatty acid medicines |
|---|---|
| INN | Omega-3 fatty acid medicines |
| More information | Omega-3 fatty acid medicines no longer considered effective in preventing heart disease |
| Name of medicine | Fyzoclad |
|---|---|
| INN | adalimumab |
| Marketing-authorisation applicant | Pfizer Europe MA EEIG |
| More information |
| Name of medicine | Canakinumab Novartis |
|---|---|
| INN | canakinumab |
| Marketing-authorisation applicant | Novartis Europharm Limited |
| More information |