Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2018
NewsHumanBiosimilarsMedicinesRare diseasesReferralsVaccines
The CHMP recommended six medicines for approval, three extensions of indications and elected its new vice-chair at its October 2018 meeting.
Six medicines recommended for approval, including two orphan medicines1
The CHMP recommended granting a marketing authorisation for Takhzyro (lanadelumab), the first monoclonal antibody therapy for the prevention of recurrent attacks of hereditary angioedema (HAE). This medicine was reviewed under EMA's accelerated assessment procedure, reserved for medicines of major public health interest. For more information, please see the press release in the grid below.
The Committee recommended granting a marketing authorisation for Namuscla (mexiletine hydrochloride), for the treatment of myotonia in adult patients with non-dystrophic myotonic disorders. This is the first treatment for this disease to be authorised EU-wide. For more information, please see the press release in the grid below.
The CHMP recommended granting a marketing authorisation for Dengvaxia (dengue tetravalent vaccine (live, attenuated)), the first vaccine in the EU for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in people who are between 9 and 45 years old, live in an endemic area and already had a prior dengue virus infection. For more information, please see the press release in the grid below.
The Committee adopted a positive opinion for Flucelvax Tetra (influenza vaccine surface antigen inactivated prepared in cell cultures), intended for the prevention of influenza in adults and children from 9 years of age.
The CHMP also recommended the granting of a marketing authorisation for Bevespi Aerosphere (glycopyrronium / formoterol fumarate dihydrate), for maintenance treatment of chronic obstructive pulmonary disease (COPD).
The biosimilar medicine Ogivri (trastuzumab) received a positive opinion from the CHMP for the treatment of breast and gastric cancer.
Three recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Kalydeco, Keytruda and NovoSeven.
CHMP elects new vice-chair
The Committee elected Professor Bruno Sepodes from Portugal as its new vice-chair, for a three-year mandate, starting on 15 October 2018. Professor Sepodes replaces Dr Harald Enzmann, who was elected as CHMP Chair at the September 2018 CHMP meeting. Bruno Sepodes is a member of the evaluation board of medicines at the Portuguese national competent authority - the National Authority for Medicines and Health Products (INFARMED). He has been a member of the CHMP since 2012. In parallel to his involvement in the CHMP, he was also the Chair of EMA’s Committee for Orphan Medicinal Products (COMP) from 2012 to 2018.
Agenda and minutes
The agenda of the October 2018 meeting is published on EMA's website. Minutes of the September 2018 CHMP meeting will be published in the coming weeks.
CHMP statistics
Key figures from the September 2018 CHMP meeting are represented in the graphic below.
1As 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.
Positive recommendations on new medicines
| Name of medicine | Bevespi Aerosphere |
|---|---|
| International non-proprietary name (INN) | glycopyrronium / formoterol fumarate dihydrate |
| Marketing-authorisation applicant | AstraZeneca AB |
| Therapeutic indication | Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) |
| Name of medicine | Dengvaxia |
|---|---|
| Common name | dengue tetravalent vaccine (live, attenuated) |
| Marketing-authorisation applicant | Sanofi Pasteur |
| Therapeutic indication | For the prevention of dengue caused by dengue virus serotypes 1, 2, 3 and 4 in people who are between 9 and 45 years old, live in an endemic area and already had a prior dengue virus infection. |
| More information | First vaccine for prevention of dengue |
| Name of medicine | Flucelvax Tetra |
|---|---|
| Common name | influenza vaccine surface antigen inactivated prepared in cell cultures |
| Marketing-authorisation applicant | Seqirus Netherlands B.V. |
| Therapeutic indication | Prophylaxis of influenza in adults and children from 9 years of age. |
| Name of medicine | Namuscla |
|---|---|
| INN | mexiletine hcl |
| Marketing-authorisation applicant | Lupin Europe GmbH |
| Therapeutic indication | Symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders |
| More information | First treatment for rare inherited muscle contraction disorders |
| Name of medicine | Ogivri |
|---|---|
| INN | trastuzumab |
| Marketing-authorisation applicant | MYLAN S.A.S |
| Therapeutic indication | Treatment of metastatic and early breast cancer and metastatic gastric cancer (MGC) |
| Name of medicine | Takhzyro |
|---|---|
| INN | lanadelumab |
| Marketing-authorisation applicant | Shire Pharmaceuticals Ireland Limited |
| Therapeutic indication | Treatment of angioedema attacks, prevention of angioedema attacks |
| More information | New medicine for hereditary angioedema, a rare disease causing swelling beneath the skin |
Positive recommendations on extensions of therapeutic indications
| Name of medicine | Kalydeco |
|---|---|
| INN | ivacaftor |
| Marketing-authorisation applicant | Vertex Pharmaceuticals (Europe) Ltd |
| Name of medicine | Keytruda |
|---|---|
| INN | pembrolizumab |
| Marketing-authorisation applicant | Merck Sharp & Dohme B.V. |
| Name of medicine | NovoSeven |
|---|---|
| INN | eptacog alfa (activated) |
| Marketing-authorisation applicant | Novo Nordisk A/S |
Outcomes of arbitration procedures
| Name of medicine | Paclitaxel Hetero |
|---|---|
| INN | paclitaxel, 6 mg/ml concentrate for solution for infusion |
| Marketing-authorisation applicant | Hetero Europe S.L. |
| Name of medicine | Perlinring 0.120mg/0.015mg per 24 hours Vaginal Delivery System |
|---|---|
| INN | etonogestrel and ethinylestradiol |
| Marketing-authorisation applicant | Actavis Group PTC EHF |