CHMP’s Positive Opinions In February Include Lokelma, Natpar and Varuby
Executive Summary
EMA committee's marketing approval recommendations from their February meeting.
The Committee for Medicinal Products for Human Use (CHMP) carries out scientific assessments for the European Medicines Agency and recommends whether medicines submitted through the centralized procedure should be granted marketing authorizations. The committee also prepares scientific and regulatory guidelines and monitors adverse drug reaction reports.
Once approved by the European Commission, a centralized marketing authorization is valid in all EU member states as well as Iceland, Liechtenstein and Norway. Here are the highlights of the CHMP’s Feb. 20 to Feb. 23, 2017 meeting, released on Feb. 24:
|
Company |
Product |
Recommendations |
Comment |
|
CHMP Positive Opinion on First Approval |
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|
Lokelma (sodium zirconium cyclosilicate) |
Hyperkalemia |
A powder for oral suspension. |
|
|
Shire PLC |
Natpar (parathyroid hormone) |
Hypoparathyroidism not adequately controlled by calcium and vitamin D |
First PTH hormone replacement therapy, and conditional approval recommended. |
|
Varuby (rolapitant) |
Prevention of delayed nausea and vomiting, as part of combo therapy |
Associated with emetogenic cancer chemotherapy. |
|
|
KrKa DD |
emtricitabine/tenofovir disoproxil |
HIV infection |
A generic of Gilead’s Truvada, authorized in the EU since 2005. |
|
Hospira Inc. (Pfizer Inc.) |
pemetrexed |
Unresectable malignant pleural mesothelioma, and locally advanced or metastatic non-small cell lung cancer |
A generic of Lilly’s Alimta, authorised in the EU since 2004. |
|
CHMP Positive Opinion On Supplemental Approval |
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|
Darzalex (daratumumab) |
In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for adults with multiple myeloma who have received at least one prior therapy |
Was also recommended for full approval, as all specific obligations of the previous conditional approval have been fulfilled. |
|
|
Novartis AG |
Mekinist (trametinib) |
In combination with dabrafenib for adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation |
The combo would become the first targeted therapy for these patients. It is already indicated for treating melanoma. |
|
Tafinlar (dabrafenib) |
In combination with trametinib for adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation |
The combo would become the first targeted therapy for these patients. It is already indicated for treating melanoma. |
|
|
Gilead Sciences Inc. |
Truvada (emtricitabine/tenofovir disoproxil)
|
HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to <18 years |
Already approved for use in HIV-1 infected adults. |
|
Labeling Update |
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|
Viekirax (ombitasvir, paritaprevir, ritonavir) plus Exviera (dasabuvir) |
Genotype 1b hepatitis C with minimal or moderate fibrosis |
An eight-week regimen recommended for approval in previously untreated patients. |
|
|
CHMP Communication |
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|
AstraZeneca PLC, Janssen-Cilag International, Boehringer Ingelheim GMBH
|
Ebymect (dapagliflozin/metformin), Edistride (dapagliflozin), Forxiga (dapagliflozin), Invokana (canagliflozin), Jardiance (empagliflozin), Synjardy (empagliflozin/metformin), Vokanamet (canagliflozin/metformin) and Xigduo (dapagliflozin/metformin) |
Type 2 diabetes, all SGLT2 inhibitors |
Warning about an increased risk of lower limb amputation (mainly toes) recommended. Patients to be reminded to check feet regularly. |
|
Janssen-Cilag International and other companies |
Haldol (haloperidol) and generics, tablets, oral solutions and injectable solutions |
Labeling harmonized across the EU |
Previously approved under national procedures. |
|
Janssen-Cilag International and other companies |
Haldol Decanoate (haloperidol decanoate) injection, and generics |
Labeling harmonized across the EU |
Previously approved under national procedures. |
|
Numerous companies |
amitriptyline |
Labeling harmonized across the EU |
Previously approved under national procedures. |