March 2, 2016 / Bio Valley BIOON / - Recently, the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) has frequently published good news, recommending 6 drugs listed in the EU, including 2 orphans medicine.

1.,

Alprolix, a recombinant long-acting clotting factor therapy drug, was approved by the FDA in March 2014 and is currently approved for use in the United States, Canada, Japan, Australia and New Zealand. Treatment of hemophilia B is designed to prevent and control bleeding episodes. Previously, Alprolix was granted orphan drug status by the FDA, resulting in an additional 7 years of market protection.

2. Jet Bellin Idelvion

Idelvion (recombinant coagulation factor-albumin fusion protein), which fuses the IX gene with the recombinant albumin gene to extend the half-life of factor IX, and is approved for use in congenital factor IX deficiency in Canada (type B hemophilia) The treatment and prevention of bleeding events in patients. At present, Jetbelin has submitted a listing application to Idelvion to drug review agencies in the United States, Australia, Switzerland and Japan. In June 2012, Idelvion was granted FDA-approved orphan drug status.

3. Servier Lonsurf

Lonsurf is a novel anti-metabolic combination of anti-tumor nucleoside analog FTD (trifluridine) and thymidine phosphorylase inhibitor TPI (tipiracil) for other therapies (chemotherapy and biotherapy) Treatment of patients with refractory metastatic colorectal cancer (mCRC) who are no longer responding. Among them, FTD can replace thymine directly into the DNA double strand during DNA replication, which interferes with the synthesis of DNA in cancer cells; TPI can inhibit the thymocyte phosphorylase associated with FTD decomposition and reduce the degradation of FTD. Clinical trials showed a significant 32% reduction in metastatic colorectal cancer mortality in the Lonsurf-treated group compared with the placebo group. Developed by Otsuka Pharmaceuticals, Lonsurf was approved by the Japanese regulatory authorities in March 2014 and the European commercialization rights are vested in Servier.

4. Gilead Descovy

The Gilead AIDS pipeline has recently received good news on EU regulation. CHMP supports the approval of the new HIV compound F/TAF (emtricitabine/tenofovir alafenamide, emtricitabine/tenofovir alafenamide, 200/10mg and 200 /25mg), in combination with other HIV antiretroviral drugs for HIV-1 adult infections, and HIV adolescents aged 12 and older and weighing at least 35 kg.

TAF is a novel nucleoside reverse transcriptase inhibitor (NRTI) that has been shown in clinical trials to be less than one tenth of the dose of Gilead's marketed Viread (Tefofuril, TDF). It has a very high antiviral effect while improving renal function and bone parameters. (See “Heavy! Gilead HIV compound new drug Descovy (F/TAF) approved by EU CHMP support, listed in the EU within 2-3 months”)

5.

Taltz (ixekizumab), a monoclonal Antibody targeting the pro-inflammatory cytokine IL-17A, is used for moderate to severe plaque psoriasis for systemic therapy (systemic therapy) Treatment of adult patients. Clinical trials showed that patients with psoriasis received a 4-week or 2-week treatment compared with the placebo group, and at week 12, 78% and 90% of patients had significant lesion area and severity index scores. Reduced by 75%.

6.Hospira Palonosetron

The Palonosetron generic drug launched by Hospira is mainly used to suppress nausea and vomiting caused by chemotherapy. Recently, it has obtained positive regulatory opinions from CHMP and is expected to be listed soon. (Bio Valley Bioon.com)