India: European Medicines Agency (EMA): Recommends Approval Of Six Medicines In Its January Meeting

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval, including two biosimilar and two generic medicines at its January 2019 meeting12.

The six medicines recommended for approval are:

1. Ajovy- for the Prophylaxis of migraine

On January 31, 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ajovy, intended for prophylaxis of migraine.

Ajovy will be available as a 225-mg solution for injection. The active substance of Ajovy is fremanezumab, an analgesic that works by binding to calcitonin gene-related peptide (CGRP). The benefits with Ajovy are its ability to reduce the number of monthly migraine days.

The applicant for Ajovy is Teva GmbH13.

2. Vizimpro - for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations

On January 31, 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Vizimpro, intended for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) activating mutation.

Vizimpro will be available as film-coated tablets (15, 30 and 45 mg). The active substance of Vizimpro is dacomitinib, a pan-human EGFR (EGFR/HER1, HER2, and HER4) inhibitor, with activity against mutated EGFR with deletions in exon 19 or L858R substitution in exon 21. The benefits with Vizimpro are its ability to increase progression free survival compared with gefitinib.

The applicant for Vizimpro is Pfizer Europe MA EEIG14.

3. Atazanavir Krka - for the treatment HIV-1 infection in adults and children 6 years of  age and older On January 31, 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Atazanavir Krka, intended for for the treatment of HIV-1 infection in adults and children 6 years of age and older.

Atazanavir Krka will be available available as hard capsules (150 mg, 200 mg and 300 mg). The active substance of Atazanavir Krka is atazanavir, an inhibitor of the viral protease enzyme which is key for viral replication.

The applicant for Atazanavir is KRKA, d.d., Novo mesto15.

4. Febuxostat Krka for Prevention and treatment of hyperuricaemia

On January 31, 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Febuxostat Krka, intended for the prevention and treatment of hyperuricaemia.

Febuxostat Krka will be available as film-coated tablets (80 and 120 mg). The active substance of Febuxostat Krka is febuxostat, which decreases serum uric acid by selectively inhibiting xanthine oxidase. Febuxostat Krka is a generic of Adenuric, which has been authorised in the EU since 21 April 2008.

The applicant for Febuxostat is KRKA, d.d., Novo mesto16.

5. Idacio for treatment of certain inflammatory and autoimmune disorders

On January31, 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Idacio, intended for the treatment of certain inflammatory and autoimmune disorders.

Idacio will be available as a solution for injection (40 mg in pre-filled syringe and pre-filled pen and 40 mg/0.8 ml for paediatric use). The active substance of Idacio is adalimumab, a tumour necrosis factor alpha (TNFα) inhibitor. Adalimumab binds to TNF and blocks its interaction with the p55 and p75 cell-surface TNF receptors. Idacio is a biosimilar medicinal product. It is highly similar to the reference product Humira (adalimumab), which was authorised in the EU on 8 September 2003.

The applicant for Idacio is Fresenius Kabi Deutschland GmbH17.

6. Kromeya for treatment of certain inflammatory and autoimmune disorders

On January 31, 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Kromeya, intended for the treatment of certain inflammatory and autoimmune disorders.

Kromeya will be available as a solution for injection (40 mg in pre-filled syringe and pre-filled pen and 40 mg/0.8 ml for paediatric use). The active substance of Kromeya is adalimumab, a tumour necrosis factor alpha (TNFα) inhibitor. Kromeya is a biosimilar medicinal product. It is highly similar to the reference product Humira (adalimumab), which was authorised in the EU on 8 September 2003.

The applicant for Kromeya is Fresenius Kabi Deutschland GmbH18.

B. CHMP negative recommendation for Doxolipad

The CHMP adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Doxolipad, intended for the treatment of breast and ovarian cancer. Doxolipad is a cancer medicine that contains the active substance doxorubicin. It was to be available as a concentrate to be made into a solution for infusion (drip) into a vein.

The CHMP's main concerns that led to the refusal is the results of the bioequivalence study showed that Doxolipad is comparable to Caelyx in terms of 'liposome-encapsulated doxorubicin', but failed to show that the amount of 'free doxorubicin' is the same for the two medicines.

Therefore, the CHMP was of the opinion that there was insufficient evidence to show that Doxolipad was bioequivalent to Caelyx, and it was not possible to establish that the benefits of Doxolipad outweigh its risks

C. CHMP recommendations on extensions of therapeutic indication

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a change to the terms of the marketing authorisation for nine drugs via extensions of therapeutic indications as described in table (New indication are marked in bold, and removed indication are marked in strikethrough)

Sl.no. Name of medicine Full Indication Marketing-authorisation holder
1 Edistride (dapagliflozin) Edistride is indicated in adults for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise, to improve glycaemic control, as monotherapy when metformin is considered inappropriate due to intolerance.
in addition to other medicinal products for the treatment of type 2 diabetes.
type 1 diabetes mellitus as an adjunct to insulin in patients with BMI 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.
AstraZeneca AB
2 Forxiga (dapagliflozin Forxiga is indicated in adults for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise, to improve glycaemic control,
− as monotherapy when metformin is considered inappropriate due to intolerance.
− in addition to other medicinal products for the treatment of type 2 diabetes.
type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.
AstraZeneca AB
3 Hemlibra (emicizumab Hemlibra is proposed for the treatment for routine prophylaxis of bleeding episodes in patients with:
haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.
severe haemophilia A (congenital factor VIII deficiency, FVIII<1 %) without FVIII inhibitors.
Hemlibra can be used in all age groups.
Roche Registration GmbH
4 Keytruda (pembrolizumab) The CHMP adopted a new indication as follows:
KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults.
Merck Sharp & Dohme B.V.
5 Mabthera (rituximab The CHMP adopted a new indication as follows:
MabThera is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Roche Registration GmbH
6 Maviret (glecaprevir / pibrentasvir) Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and in adolescents aged 12 to <18 years. AbbVie Deutschland GmbH & Co. KG
7 Orencia (abatacept) The existing indication for Orencia 250 mg powder for concentrate for solution for infusion for Polyarticular juvenile idiopathic arthritis: Orencia in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in paediatric patients 6 years of age and older who have had an insufficient inadequate response to other DMARDs including at least one TNF inhibitor previous DMARD therapy.
Orencia can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate.
Bristol-Myers Squibb Pharma EEIG
8 Praluent (alicocumab) The CHMP adopted a new indication as follows:
"Established atherosclerotic cardiovascular disease Praluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
- in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,
- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
sanofi-aventis groupe
9 Tecentriq (atezolizumab) Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC): after prior platinum-containing chemotherapy, or who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% .
Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC). In patients with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies.
Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. Patients with EGFR activating mutations mutant or ALK-positive tumour mutations NSCLC should also have received targeted therapyies before receiving Tecentriq.
Roche Registration GmbH

Note - The CHMP's assessments are based on a comprehensive scientific evaluation of data. They determine whether the medicine meets the necessary quality, safety and efficacy requirements and that it has a positive risk-benefit balance. The CHMP carry out a scientific assessment of the application and give a recommendation on whether the medicine should be marketed or not. Once granted by the European Commission, the centralised marketing authorisation is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.

Footnotes

12. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-28-31-january-2019

13. https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-ajovy_en.pdf

14. https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-vizimpro_en.pdf

15. https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-atazanavir-krka_en.pdf

16. https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-febuxostat-krka_en.pdf

17. https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-idacio_en.pdf

18. https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-kromeya_en.pdf

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