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

  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2017
  • Ten medicines recommended for approval, including two orphans

The European Medicines Agency (EMA) on November 11, 2017, announced that its Committee for Medicinal Products for Human Use (CHMP) is recommending approval of six new drugs, one biosimilar and three generic medicines in the European Union (EU)1.

The six new drugs recommended for approval are:

1. Jorveza (Budesonide) - to treat eosinophilic esophagitis, a rare inflammatory condition of the oesophagus. This medicine was reviewed under EMA's accelerated assessment mechanism, reserved for medicines of major public health interest. Jorveza has an orphan designation.

The active substance in Jorveza - Budesonide, is a well-known glucocorticosteroid that has been authorized since many years for the treatment of autoimmune disorders such as asthma and inflammatory bowel disease in different presentations. Budesonide as inhalation spray has been used off-label in the treatment of patients with eosinophilic esophagitis and its effects on the inflamed oesophageal mucosa of these patients have been extensively described in the scientific literature2.

The applicant for Jorveza is Dr. Falk Pharma GmbH.

2. Prevymis (Letermovir), an antiviral medicine that prevents cytomegalovirus (CMV) reactivation and disease in patients who receive immunosuppressant medicines following an allogeneic haematopoietic stem cell transplant. Prevymis has an orphan designation.

CMV is a common virus that usually causes only mild infections such as a sore throat. But after infection, the virus remains in the body in a latent state and can become active again and cause a severe disease if the body's immunity is compromised, for instance in patients who need to take medicines that prevent their body to reject a transplant. CMV disease in these patients can be life-threatening3.

The applicant for Prevymis is Merck Sharp & Dohme Limited.

3. Ocrevus (Ocrelizumab), for the treatment of adult patients with relapsing multiple sclerosis (RMS) and early primary progressive multiple sclerosis (PPMS).

Ocrevus is the first medicine to receive positive opinion for treatment of patients with early stage of primary progressive multiple sclerosis4.

Multiple sclerosis (MS) is a condition which affects the brain and/or spinal cord, causing a wide range of potential symptoms, including problems with vision, arm or leg movement, sensation or balance. It occurs more frequently in women than in men and is among the most common causes of neurological disability in young adults. In majority of patients (around 85%), MS begins as a relapsing, episodic disorder with gradual complete or incomplete recovery. For approximately 10% of patients with PPMS the disease is characterised by worsening neurological function from the onset of symptoms, without early relapses or remissions.

The applicant for Ocrevus is Roche.

4. Adynovi (Rurioctocog alfa pegol), received a positive opinion for the treatment and prophylaxis of bleeding in patients 12 years and above with Haemophilia A (congenital factor VIII deficiency).

Adynovi will be available as a powder and solvent for solution for injection (250 IU, 500 IU, 1000 IU and 2000 IU). The active substance of Adynovi is rurioctocog alfa pegol, a recombinant human factor VIII which replaces the missing coagulation factor VIII needed for effective haemostasis5.

The applicant for Adynovi is Baxalta.

5. Fasenra (Benralizumab), for the treatment of severe eosinophilic asthma.

Fasenra will be available as 30-mg solution for injection in pre-filled syringes. The active substance of Fasenra is Benralizumab, an anti-eosinophil, humanised monoclonal antibody which binds to the human interleukin-5 receptor expressed on the surface of eosinophils and basophils. This leads to apoptosis of eosinophils and basophils through enhanced antibody-dependent cell-mediated cytotoxicity, and therefore, reduces eosinophilic inflammation6.

The applicant for Fasenra is AstraZeneca.

6. Intrarosa (Prasterone), received a positive opinion for the treatment of vulvar and vaginal atrophy in postmenopausal women.

Intrarosa will be available as a 6.5 mg pessary. The active substance of Intrarosa is Prasterone, also known as Dehydroepiandrosterone (DHEA), a precursor steroid which is converted into oestrogens and androgens. The medicine increases the number of superficial and intermediate cells and decreases the number of parabasal cells in the vaginal mucosa via an oestrogen-mediated mechanism. In addition, it decreases the vaginal pH towards the normal range, thus facilitating the growth of the normal bacterial flora7.

The applicant for Intrarosa is Endoceutics.

Mvasi (bevacizumab) has been recommended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Mvasi will be available as a 25 mg/ml concentrate for solution for infusion. The active substance of Mvasi is bevacizumab, a monoclonal antibody which binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, thereby, inhibiting the binding of VEGF to its receptors on the surface of endothelial cells. Neutralising the biological activity of VEGF regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth8.

Mvasi is a biosimilar medicinal product, similar to the reference product Avastin (bevacizumab). Data shows that Mvasi has comparable quality, safety and efficacy to Avastin.

The applicant for Mvasi is Amgen.

The agency also recommended positive opinion on approval of Three (03) generic medicines:

Darunavir Krka (darunavir) and

Darunavir Krka d.d. (darunavir): both for the treatment of human immunodeficiency virus (HIV-1) infection. Darunavir Krka will be available as film-coated tablets (400 mg, 600 mg and 800 mg). The active substance of Darunavir Krka is darunavir, a protease inhibitor. It acts by inhibiting the HIV enzyme protease, thus preventing formation of mature virus. Darunavir KrKa must be given with a small dose of ritonavir (as a booster), which decreases the breakdown of darunavir in the liver, resulting in higher levels of darunavir in the blood9.

Darunavir Krka d.d. will be available as film-coated tablets (400 mg, 600 mg and 800 mg). The active substance of Darunavir Krka d.d. is darunavir, a protease inhibitor. It acts by inhibiting the HIV enzyme protease, thus preventing formation of mature virus. Darunavir Krka d.d. must be given with a small dose of ritonavir or cobicistat (as a booster), which decreases the breakdown of darunavir in the liver, resulting in higher levels of darunavir in the blood10.

Darunavir Krka, and Darunavir Krka d.d. is a generic of Prezista.

Fulvestrant Mylan (Fulvestrant), for the treatment of locally advanced or metastatic breast cancer

Fulvestrant Mylan will be available as a 250-mg solution for injection. The active substance of Fulvestrant Mylan is fulvestrant, an anti-oestrogen which attaches to the receptors for oestrogen on the surface of cells, thereby blocking the effects of the hormone and causing the number of oestrogen receptors to fall. As a result, the tumour cells are not stimulated to grow by oestrogen and the growth of the tumour is reduced11.

Fulvestrant Mylan is a generic of Faslodex

Four recommendations on extensions of therapeutic indication

The Committee recommended extensions of indications for Adcetris, Genvoya, Nplate and Orkambi.

Outcome of review on Zinbryta

The CHMP concluded its review of the multiple sclerosis medicine Zinbryta (daclizumab) and confirmed further restrictions to reduce the risk of serious liver damage.

Withdrawals of applications

Applications for initial marketing authorisations for Kyomarc (bevacizumab) and Plivensia (sirukumab) have been withdrawn.

  • Kyomarc was intended to be used to treat cancer of the colon or rectum, breast cancer, non-small cell lung cancer, kidney cancer, cervical cancer, and cancer of the ovary, the fallopian tube, or the peritoneum.
  • Plivensia was intended to be used to treat rheumatoid arthritis.













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