European Union: European Medicines Agency (EMA): Recommends Approval Of Four Medicines In Its November Meeting

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.

  1. The four medicines recommended for approval are:
  1. 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.

  1. 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.

  1. 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.

  1. 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.

  1. 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)

  • MabThera is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
  • MabThera maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
  • MabThera monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.
  • MabThera is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.

Chronic lymphocytic leukaemia (CLL)

  • MabThera in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including MabThera or patients refractory to previous MabThera plus chemotherapy.

Rheumatoid arthritis

  • MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease modifying anti rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.
  • MabThera has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function, when given in combination with methotrexate.

Granulomatosis with polyangiitis and microscopic polyangiitis

  • MabThera, in combination with glucocorticoids, is indicated for the induction of remission in treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).

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)

  • Ravicti is indicated for use as adjunctive therapy for chronic management of adult and paediatric patients ≥ 2 months of age with urea cycle disorders (UCDs) including deficiencies of carbamoylmphosphate synthetase I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
  • Ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).

Horizon Pharma Ireland Limited9

5

Blincyto (blinatumomab)

  • Blincyto is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL).
  • Blincyto is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
  • Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.

Amgen Europe B.V.10

6

Opdivo (nivolumab)

Melanoma

  • Opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.

Adjuvant treatment of melanoma

  • Opdivo as monotherapy is indicated for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Non-Small Cell Lung Cancer (NSCLC)

  • Opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults.

Renal Cell Carcinoma (RCC)

  • Opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.
  • Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma.

Classical Hodgkin Lymphoma (cHL)

  • Opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.

Squamous Cell Cancer of the Head and Neck (SCCHN)

  • Opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy.

Urothelial Carcinoma

  • Opdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.

urothelial carcinoma in adults after failure of prior platinum-containing therapy

Bristol-Myers Squibb Pharma EEIG11

7

Yervoy (ipilimumab)

Melanoma

  • Yervoy as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults, and adolescents 12 years of age and older.
  • Yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.

Renal Cell Carcinoma (RCC)

  • Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma.

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

1 https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-november-2018

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

3 https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-macimorelin-aeterna-zentaris_en.pdf

4 https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-silodosin-recordati_en.pdf

5 https://www.ema.europa.eu/documents/smop-initial/chmp-summary-opinion-fexinidazole-winthrop_en.pdf

6 https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-kisqali-ii-04_en.pdf

7 https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-mabthera-ii-149_en.pdf

8 https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-orkambi-x-34-g_en.pdf

9 https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-ravicti-ii-19_en.pdf

10 https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-blincyto-ii-0011_en.pdf

11 https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-opdivo-ws-1278_en.pdf

12 https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-yervoy-ws-1278_en.pdf

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