Daily Top News – June 29, 2020

June 29, 2020

Translarna (ataluren) / PTC Therap, Sanofi
PTC Therapeutics Announces CHMP Recommendation of Translarna (ataluren) Label Update for Non-Ambulatory Patients with Duchenne Muscular Dystrophy (PRNewswire) – Jun 29, 2020 – “PTC Therapeutics…today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended by a majority of votes to remove the statement ‘efficacy has not been demonstrated in non-ambulatory patients’ from the SmPC for Translarna™ (ataluren)…The change also should support reimbursement agencies granting continued access to Translarna for patients who become non-ambulatory during the course of their treatment. The CHMP’s positive opinion is subject to final approval by the European Commission, which is normally granted in a two-month time frame.”

 

cetuximab sarotalocan (ASP-1929) / Rakuten Medical
Rakuten Medical Receives Conditional Early Approval Designation from Japanese Health Ministry for its Lead Drug, ASP-1929, to Treat Recurrent Head & Neck Cancer (PRNewswire) – Jun 29, 2020 – “Rakuten Medical, Inc…announced that the Japanese Ministry of Health, Labor, and Welfare (MHLW) has notified Rakuten Medical that its lead drug ASP-1929 will be reviewed under the Conditional Early Approval System (CEAS)….Rakuten Medical submitted a Japanese Biological License Application (JBLA) for this drug on March 26, 2020 – based on results of Phase I / II clinical trials. In addition – on March 19, 2020 – the company applied for Japan approval of the laser illumination system which is utilized in conjunction with ASP-1929.”

 

Vafseo (vadadustat) / Akebia Therap, Otsuka, Mitsubishi Tanabe
Akebia Therapeutics Announces Approval of Vadadustat in Japan for the Treatment of Anemia Due to Chronic Kidney Disease in Dialysis-Dependent and Non-Dialysis Dependent Adult Patients (PRNewswire) – Jun 29, 2020 – “Akebia Therapeutics…announced the first regulatory approval of vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD). Mitsubishi Tanabe…has obtained manufacturing and marketing approval of vadadustat as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients by the Ministry of Health, Labour and Welfare in Japan on June 29, 2020. Vadadustat will be marketed by MTPC in Japan under the trade name VAFSEO™.”

 

Duvroq (daprodustat) / GSK, Kyowa Hakko Kirin
GSK receives first regulatory approval for Duvroq (daprodustat) in Japan for patients with anaemia due to chronic kidney disease (GSK Press Release) – Jun 29, 2020 – “GlaxoSmithKline…announced the approval of a Japanese New Drug Application (JNDA) by the Ministry of Health, Labour and Welfare for Duvroq (daprodustat) tablets, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of patients with anaemia due to chronic kidney disease (CKD).”

 

Enspryng (satralizumab) / Roche
Chugai’s Enspryng (Satraliazumab) Subcutaneous Injection 120 mg Syringe Approved in Japan for Neuromyelitis Optica Spectrum Disorder (Chugai Press Release) – Jun 29, 2020 – “Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that the new drug application was approved by the Ministry of Health, Labour and Welfare (MHLW) for…Enspryng® Subcutaneous Injection 120 mg Syringe (generic name: satralizumab) (hereafter, Enspryng) for the prevention of relapses of neuromyelitis optica spectrum disorder (including neuromyelitis optica)….’In addition, Enspryng, which was the first to apply our proprietary recycling antibody technology, can be subcutaneously administered every four weeks for convenience.’…This approval is based on the results from 2 global phase III clinical studies in patients with NMOSD: SAkuraSky Study (NCT02028884) and SAkuraStar Study (NCT02073279).”

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