The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended four medicines for approval, including a medicine for use in countries outside the European Union, at its November 2018 meeting1.
- The four medicines recommended for approval are:
- Erleada - for the treatment of non-metastatic castration resistant prostate cancer
On November 15, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Erleada, intended for the treatment of non-metastatic castration resistant prostate cancer.
Erleada will be available as 60-mg tablets. The active substance of Erleada is apalutamide, a selective androgen receptor inhibitor that binds directly to the ligand binding domain of the androgen receptor. The benefits with Erleada are its ability to delay metastatic disease.
The applicant for Erleada is Janssen-Cilag International N.V2.
- Macimorelin Aeterna Zentaris - for the diagnosis of growth hormone deficiency in adults
On November 15, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Macimorelin Aeterna Zentaris intended for the diagnosis of growth hormone deficiency in adults.
Macimorelin Aeterna Zentaris will be available as 60 mg granules for oral solution. The active substance of Macimorelin Aeterna Zentaris is macimorelin, a peptide mimetic with growth hormone secretagogue activity similar to ghrelin (ATC code: V04CD06). Macimorelin stimulates growth hormone release by activating growth hormone secretagogue receptors present in the pituitary and hypothalamus.
The applicant for Macimorelin is Aeterna Zentaris GmbH3.
- Silodosin Recordati - for the treatment of the signs and symptoms of benign prostatic hyperplasia
On November 15, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Silodosin Recordati, intended for the treatment of the signs and symptoms of benign prostatic hyperplasia.
Silodosin Recordati will be available as 4-mg and 8-mg capsules. The active substance of Silodosin Recordati is silodosin, a α1A-adrenoreceptor antagonist (ATC code: G04CA04) that decreases the bladder outlet resistance and improves storage (irritative) and voiding (obstructive) lower urinary tract symptoms. Silodosin Recordati is a generic of Urorec which has been authorized in the EU since January 29, 2010.
The applicant for Silodosin is Recordati Ireland Ltd4.
- Fexinidazole Winthrop - for the treatment of human African trypanosomiasis (HAT)
On November 15, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, in accordance with Article 58 of Regulation (EC) No 726/20041 for the medicinal product Fexinidazole Winthrop, intended for the treatment of human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in adults and children ≥ 6 years old and weighing ≥ 20 kg.
Fexinidazole Winthrop will be available as 600-mg tablets. The active substance of Fexinidazole Winthrop is fexinidazole, a nitro-imidazole derivative that generates reactive amines that exert indirect toxic and mutagenic effects on the trypanosomes. Fexinidazole Winthrop has been shown to be effective at curing the disease (measured as the number of patients having no evidence of trypanosomes in any body fluid, not requiring rescue medication and having a cerebrospinal fluid white blood cell count ≤20 cells/μL).
Fexinidazole Winthrop has been developed by DNDi and Sanofi-Aventis Groupe and intended exclusively for markets outside the European Union5.
- 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 authorization for seven drugs on extensions of therapeutic indication 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 |
Kisqali (ribociclib) |
Kisqali in combination with an aromatase inhibitor is indicated for the treatment of postmenopausal women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine based therapy or in women who have received prior endocrine therapy. In pre or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone releasing hormone (LHRH) agonist. |
Novartis Europharm Limited6 |
2 |
Mabthera (rituximab) |
MabThera is indicated in adults for the following indications: Non-Hodgkin's lymphoma (NHL)
Chronic lymphocytic leukaemia (CLL)
Rheumatoid arthritis
Granulomatosis with polyangiitis and microscopic polyangiitis
|
Roche Registration GmbH7 |
3 |
Orkambi (lumacaftor / ivacaftor) |
Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in children aged 2 years and older who are homozygous for the F508del mutation in the CFTR gene. |
Vertex Pharmaceuticals (Europe) Ltd8 |
4 |
Ravicti (glycerol phenylbutyrate) |
|
Horizon Pharma Ireland Limited9 |
5 |
Blincyto (blinatumomab) |
|
Amgen Europe B.V.10 |
6 |
Opdivo (nivolumab) |
Melanoma
Adjuvant treatment of melanoma
Non-Small Cell Lung Cancer (NSCLC)
Renal Cell Carcinoma (RCC)
Classical Hodgkin Lymphoma (cHL)
Squamous Cell Cancer of the Head and Neck (SCCHN)
Urothelial Carcinoma
urothelial carcinoma in adults after failure of prior platinum-containing therapy |
Bristol-Myers Squibb Pharma EEIG11 |
7 |
Yervoy (ipilimumab) |
Melanoma
Renal Cell Carcinoma (RCC)
|
Bristol-Myers Squibb Pharma EEIG12 |
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 carries out a scientific assessment of the application and gives a recommendation on whether the medicine should be marketed or not. Once granted by the European Commission, the centralized marketing authorization is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.
Footnotes
2 https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-erleada_en.pdf
5 https://www.ema.europa.eu/documents/smop-initial/chmp-summary-opinion-fexinidazole-winthrop_en.pdf
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