Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 January 2015
Seven new medicines recommended for approval
Seven new medicines have been recommended for approval at the January 2015 meeting of the Committee for Medicinal Products for Human Use (CHMP).
The Committee has recommended granting a marketing authorisation for Saxenda (liraglutide) for weight management in adults who are obese, or those who are overweight and have one or more complications related to their weight. The medicine is recommended for use in addition to a reduced-calorie diet and physical activity. For more information please see the press release in the grid below.
The CHMP also gave positive opinions for Orbactiv (oritavancin) and Sivextro (tedizolid phosphate), two antibiotics for the treatment of acute bacterial skin and skin structure infections.
Dutrebis (lamivudine / raltegravir) was recommended by the Committee as a new treatment option for human immunodeficiency virus (HIV-1).
Ikervis (ciclosporin) was recommended for the treatment of severe keratitis, an eye condition in which the cornea becomes inflamed.
Kengrexal (cangrelor) received a positive opinion from the Committee for the reduction of thrombotic cardiovascular events and Raplixa (human fibrinogen / human thrombin) received a positive opinion as a supportive treatment where standard surgical techniques are insufficient for the improvement of haemostasis.
Five recommendations on extensions of therapeutic indication
The Committee recommended extensions of indications for Abraxane, Aloxi, Eylea, Jakavi and Prevenar 13.
Outcome of GVK Biosciences review
The CHMP concluded that a number of medicines for which authorisation in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India should be suspended, unless they are of critical importance for patients because alternatives will not be able to meet patients' needs. The CHMP's recommendation is based on findings from an inspection that raised concerns over how GVK conducted studies at the Hyderabad site on behalf of marketing authorisation holders.
For more information on the review, and for the list of affected medicines, please see the public health communication in the grid below.
Withdrawal of application
An application for extension of therapeutic indication for Teysuno has been withdrawn. A question-and-answer document on this withdrawal is available below.
Agenda and minutes
The agenda of the January 2015 meeting is published on the EMA website. The minutes of the meeting will be published during the week following the February CHMP meeting.
CHMP statistics
Key figures from the January 2015 CHMP meeting are represented in the graphic below.
Positive recommendations on new medicines
| Name of medicine | Dutrebis |
|---|---|
| International non-proprietary name (INN) | lamivudine / raltegravir |
| Marketing-authorisation applicant | Merck Sharp & Dohme Limited |
| Therapeutic indication | Treatment of human immunodeficiency virus (HIV-1) |
| More information |
Summary of opinion for Dutrebis
|
| Name of medicine | Ikervis |
|---|---|
| INN | ciclosporin |
| Marketing-authorisation applicant | Santen SAS |
| Therapeutic indication | Treatment of severe keratitis |
| More information |
Summary of opinion for Ikervis
|
| Name of medicine | Kengrexal |
|---|---|
| INN | cangrelor |
| Marketing-authorisation applicant | The Medicines Company UK Ltd |
| Therapeutic indication | Reduction of thrombotic cardiovascular events |
| More information |
Summary of opinion for Kengrexal
|
| Name of medicine | Orbactiv |
|---|---|
| INN | oritavancin |
| Marketing-authorisation applicant | The Medicines Company UK Ltd |
| Therapeutic indication | Treatment of acute bacterial skin and skin structure infections |
| More information |
Summary of opinion for Orbactiv
|
| Name of medicine | Raplixa |
|---|---|
| INN | human fibrinogen / human thrombin |
| Marketing-authorisation applicant | ProFibrix BV |
| Therapeutic indication | Supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis |
| More information |
| Name of medicine | Saxenda |
|---|---|
| INN | liraglutide |
| Marketing-authorisation applicant | Novo Nordisk A/S |
| Therapeutic indication | Treatment of obesity |
| More information |
Press release: Saxenda recommended for approval in weight management in adults |
| Name of medicine | Sivextro |
|---|---|
| INN | tedizolid phosphate |
| Marketing-authorisation applicant | Cubist |
| Therapeutic indication | Treatment of acute bacterial skin and skin structure infections |
| More information |
Summary of opinion for Sivextro
|
Positive recommendations on new therapeutic indications
| Name of medicine | Abraxane |
|---|---|
| INN | paclitaxel |
| Marketing-authorisation holder | Celgene Europe Limited |
| More information |
Summary of opinion for Abraxane
|
| Name of medicine | Aloxi |
|---|---|
| INN | palonosetron |
| Marketing-authorisation holder | Helsinn Birex Pharmaceuticals Ltd |
| More information |
Summary of opinion for Aloxi
|
| Name of medicine | Eylea |
|---|---|
| INN | aflibercept |
| Marketing-authorisation holder | Bayer Pharma AG |
| More information |
Summary of opinion for Eylea
|
| Name of medicine | Jakavi |
|---|---|
| INN | ruxolitinib |
| Marketing-authorisation holder | Novartis Europharm Ltd |
| More information |
Summary of opinion for Jakavi
|
| Name of medicine | Prevenar 13 |
|---|---|
| INN | pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) |
| Marketing-authorisation holder | Pfizer Limited |
| More information |
Summary of opinion for Prevenar 13
|
Public-health recommendation
| Name of referral | GVK Biosciences |
|---|---|
| More information | GVK Biosciences |
Withdrawal of application
| Name of medicine | Teysuno |
|---|---|
| More information |
Questions and answers on Teysuno
|