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

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended six medicines for approval, including one orphan medicine, at its March 2018 meeting21.

A) THE SIX MEDICINES RECOMMENDED FOR APPROVAL ARE:

1) Rubraca (Rucaparib) – For treatment of relapsed or progressive ovarian cancer

On March 22, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Rubraca, intended for the treatment of relapsed or progressive ovarian cancer22. Rubraca was designated as an orphan medicinal product on October 10, 2012.

Rubraca will be available as 200 mg, 250 mg and 300 mg film-coated tablet. The active substance of Rubraca is rucaparib, an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes (ATC code: L01XX55) that blocks the repair of damaged DNA in cancer cells, and, as a result, causes the cancer cells to die. The benefits with Rubraca are its anti-tumour activity as measured by objective response rate and response duration as well its safety profile. The full indication is: "monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy".

The applicant for this medicinal product is Clovis Oncology UK Ltd.

2) Juluca (Dolutegravir / Rilpivirine) - For treatment of HIV infection

On March 22, 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 Juluca, intended for the treatment of HIV infection23.

Juluca is a fixed-dose combination of two active substances, dolutegravir and rilpivirine (ATC code: J05AR21), and will be available as 50 mg/25 mg film-coated tablets. Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral DNA integration which is essential for HIV replication. Rilpivirine activity is mediated by non-competitive inhibition of HIV1 reverse transcriptase. The benefit with Juluca is its ability to maintain viral suppression of HIV strains that lack resistance (documented or clinically suspected) to integrase inhibitors.

The full indication is - "Juluca is indicated for the treatment of human immunodeficiency virus type 1 (HIV1) infection in adults who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non- nucleoside reverse transcriptase inhibitor or integrase inhibitor."

The applicant for this medicinal product is ViiV Healthcare UK Limited.

3) Kanjinti (Trastuzumab) - For the treatment of breast and gastric cancer

On March 22, 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 Kanjinti, intended for the treatment of breast and gastric cancer24.

Kanjinti will be available as powder for concentrate for solution for infusion (150 mg and 420 mg). The active substance of Kanjinti is trastuzumab, a monoclonal antibody (ATC code: L01XC03) that binds with high affinity and specificity to HER2 leading to the inhibition of proliferation of tumour cells that overexpress HER2.

Kanjinti is a biosimilar medicinal product. It is highly similar to the reference product Herceptin (trastuzumab), which was authorized in the EU on August 28, 2000. Data shows that Kanjinti has comparable quality, safety and efficacy to Herceptin (trastuzumab).

The applicant for this medicinal product is Amgen Europe B.V., BREDA.

4) Zessly (Infliximab) – For the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis

On March 22, 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 Zessly, intended for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis25.

Zessly will be available as a 100 mg powder for concentrate for solution for infusion. The active substance of Zessly is infliximab, a tumour necrosis factor alpha (TNF-α) inhibitor (ATC code: L04AB02). Infliximab is a chimeric human murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNF-α. Zessly is a biosimilar medicinal product. It is highly similar to the reference product Remicade (infliximab), which was authorized in the EU on August 13, 1999. Data shows that Zessly has comparable quality, safety and efficacy to Remicade (infliximab).

The applicant for this medicinal product is Sandoz GmbH.

5) Pemetrexed Krka (Pemetrexed) – For the treatment of malignant pleural mesothelioma and non-small cell lung cancer

On March 22, 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 Pemetrexed Krka, intended for the treatment of malignant pleural mesothelioma and non-small cell lung cancer26.

Pemetrexed Krka will be available as a powder (100 mg and 500 mg) for concentrate for solution for infusion. The active substance of Pemetrexed Krka, pemetrexed, is a multi-targeted anti-cancer antifolate agent (ATC code: L01BA04) that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.

Pemetrexed Krka is a generic of Alimta, which has been authorized in the EU since September 20, 2004. Studies have demonstrated the satisfactory quality of Pemetrexed Krka. Since Pemetrexed Krka is administered intravenously and is 100% bioavailable, a bioequivalence study versus the reference product Alimta was not required.

The applicant for this medicinal product is Krka d.d.

6) Prasugrel Mylan (Prasugrel) – For the Prevention of atherothrombotic events

On March 22, 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 Prasugrel Mylan, intended to be given with acetylsalicylic acid for the prevention of atherothrombotic events in adults with acute coronary syndromes who are undergoing percutaneous coronary intervention27.

Prasugrel Mylan will be available as 5- and 10-mg film-coated tablets. The active substance of Prasugrel Mylan is prasugrel, an inhibitor of platelet activation and aggregation (ATC code: B01AC22). Prasugrel acts through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Since platelets participate in the initiation and/or evolution of thrombotic complications of atherosclerotic disease, inhibition of platelet function can result in the reduction of the rate of cardiovascular events such as death, myocardial infarction, or stroke.

Prasugrel Mylan is a generic of Efient, which has been authorized in the EU since February 23, 2009. Studies have demonstrated the satisfactory quality of Prasugrel Mylan, and its bioequivalence to the reference product Efient. The applicant for this medicinal product is Mylan S.A.S.

B) NEGATIVE OPINIONS ON TWO NEW MEDICINES

The CHMP adopted negative opinion for the following two medicines:

1) Dexxience (Betrixaban) - Dexxience was expected to be used for the prevention of venous thromboembolism

The committee considered that the main study did not satisfactorily show that Dexxience's benefits outweighed its risk when used for preventing blood clots in patients admitted to hospital for recent medical illness. Moreover, the results of the study were not considered reliable because some results of tests for blood clots were not available. Patients treated with Dexxience had more episodes of bleeding than those treated with the comparator medicine. This was a critical concern given that the medicine was expected to be used in patients with serious underlying conditions. Therefore, the CHMP concluded that the benefits of Dexxience did not outweigh its risks and recommended that it be refused marketing authorization28.

2) Eladynos (Abaloparatide) - Eladynos was intended to be used to treat osteoporosis

The CHMP considered that the main study did not satisfactorily show that Eladynos is effective at preventing non-vertebral fractures in women who have been through menopause. The data from two of the study sites were not reliable and had to be excluded as the study had not been conducted in compliance with 'good clinical practice' (GCP) at those sites.

From a safety point of view, the CHMP was concerned about the medicine's effects on the heart, such as increased heart rate and palpitations. Because most post-menopausal women are at an increased risk of heart problems, the CHMP could not identify a group of patients in whom the benefits would outweigh the risks. Therefore, the committee recommended that the medicine be refused marketing authorization29.

C) RECOMMENDATION ON EXTENSIONS OF THERAPEUTIC INDICATION

The Committee recommended extensions of indications for three medicines as below

1) Cabometyx (Cabozantinib)

On March 22, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorization for the medicinal product Cabometyx30. The CHMP adopted an extension to the existing indication as follows:

"Cabometyx is indicated for the treatment of advanced renal cell carcinoma (RCC):

  • In treatment of naïve adults with intermediate or poor risk
  • In adults following prior vascular endothelial growth factor (VEGF)-targeted therapy." The marketing authorization holder for this medicinal product is Ipsen Pharma.

2) Ivemend (Fosaprepitant)

On March 22, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change in the terms of the marketing authorization for the medicinal product Ivemend31.

The CHMP adopted an extension to the existing indication as follows:

  • "Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and paediatric patients aged 6 months and older. IVEMEND 150 mg is given as part of a combination therapy."

The marketing authorization holder for this medicinal product is Merck Sharp & Dohme Limited.

3) Repatha (Evolocumab)

On March 22, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change in the terms of the marketing authorization for the medicinal product Repatha32.

The CHMP adopted a new indication as follows:

  • Established atherosclerotic cardiovascular disease

    Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial 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."

The marketing authorization holder for this medicinal product is Amgen Europe B.V.

D) OUTCOME OF REVIEW ON RETINOID MEDICINES

  • Updated measures for prevention of pregnancy during retinoid use
  • Warning on possible risk of neuropsychiatric disorders also to be included for oral retinoids

The European Medicines Agency (EMA) has completed its review of retinoid medicines and confirmed that an update in measures for prevention of pregnancy is needed. In addition, a warning on the possibility that neuropsychiatric disorders (such as depression, anxiety and mood changes) may occur, will be included in the prescribing information for oral retinoids (those taken by mouth)33.

Retinoids include the active substances acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene and tretinoin. They are taken by mouth or applied as creams or gels to treat several conditions mainly affecting the skin, including severe acne and psoriasis. Some retinoids are also used to treat certain forms of cancer.

The review confirmed that oral retinoids can harm the unborn child and must not be used during pregnancy. In addition, the oral retinoids acitretin, alitretinoin and isotretinoin, which are used to treat conditions mainly affecting the skin, must be used in accordance with the conditions of a new pregnancy prevention programme by women able to have children.

Topical retinoids (those applied to the skin) must also not be used during pregnancy, and by women planning to have a baby.

Footnotes

21. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/03/news_detail_002925.jsp&mid=WC0b01ac058004d5c1

22. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004272/WC500246362.pdf

23. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004427/WC500246369.pdf

24. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004361/WC500246366.pdf

25. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004647/WC500246338.pdf

26. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/003958/WC500246365.pdf

27. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004644/WC500246320.pdf

28. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004309/WC500246331.pdf

29. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004157/WC500246387.pdf

30. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/004163/WC500246393.pdf

31. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/000743/WC500246364.pdf

32. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/003766/WC500246329.pdf

33. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/03/news_detail_002928.jsp&mid=WC0b01ac058004d5c1

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