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Japan authorises exceptional approval of Gilead's remdesivir for severe COVID-19

Image credit: BlackRiver, https://commons.wikimedia.org/wiki/File:GovernmentOfficeComplexNo5.jpg

Remdesivir, perhaps the leading hope in the race against COVID-19, has secured approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) under the brand name Veklury for the treatment of severe COVID-19, its license holder Gilead has announced.

The antiviral therapy has emerged as the most effective treatment available thus far against the virus amongst a dearth of alternatives, though the mostly-positive efficacy data accumulated so far has been the subject  of criticism due to small study sizes which have often lacked control arms or have not been peer-reviewed.

First for Japan with the approval of AstraZeneca's Lokelma in hyperkalaemia

Japan’s Ministry of Health, Labour and Welfare has awarded approval to AstraZeneca’s Lokelma for the treatment of hyerkalaemia, marking the first authorisation for an innovative non-resin potassium binder in the country.

Supporting data was generated from studies conducted in Japan and around the world.

Japan grants orphan drug designation to Lynparza for BRCA+ unresectable pancreatic cancer

AstraZeneca has confirmed that its PARP inhibitor Lynparza (olaparib) has been awarded orphan drug designation in Japan for the maintenance treatment of germline BRCA-mutated (gBRCAm) curatively unresectable pancreatic cancer.

The nation’s Ministry of Health, Labour and Welfare hands out the designation to therapies designed to treat conditions for which there are less than 50,000 patients in the country.

Japan approves Novartis' Zolgensma for spinal muscular atrophy in patients under two years old

Novartis has revealed that its gene therapy Zolgensma (onasemnogene abeparvovec) has secured approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of spinal muscular atrophy (SMA) in the country in patients less than two years of age, including those who are pre-symptomatic at the time of diagnosis.

Japan welcomes approval of ViiV's Dovato for HIV-1

Japan’s Ministry of Health, Labour and Welfare (MHLW) has awarded marketing approval to ViiV Healthcare, a subsidiary of GSK, for its once-daily pill Dovato (dolutegravir 50 mg/lamivudine 300 mg) for the treatment-naïve HIV-1 infection in patients of at least 12 years old who weigh at least 40kg.

Data drawn from over 1,400 HIV-1 patients and submitted to the MHLW showed that Dovato proved non-inferior compared to the combination of dolutegravir and two NRTIs, tenofovir disoproxil fumarate/emtricitabine, in plasinma HIV-1 RNA <50 copies per millilitre (c/mL) at 48 weeks of treatm

China’s viral pneumonia spreads to Japan

A recent strain of viral pneumonia has spread from China to Japan, prompting fears of a global pandemic.

A man in his 30’s, from Kanagawa Prefecture, developed a fever on 3 January while visiting Wuhan and tested positive for the virus when he returned to Japan. He has since recovered and was discharged from hospital.

This comes days after the disease had spread to Thailand, where one man was diagnosed and 12 patients where quarantined. So far two people have died, although one of these had serious pre-existing conditions.

Lundbeck and Takeda's depression drug approved in Japan

Takeda and Lundbeck have announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has chosen to authorise their drug Trintellix (vortioxetine) for the treatment of major depressive disorder, described in the companies’ press release as “depression and depressed state”.

This marks the 84th national approval for the drug, which is already marketed in the US, Europe, China, Canada, Australia, South Africa, Mexico, Argentina, and South Korea to name a few.

Roche secures world first with Japanese Rozlytrek approval in advanced recurrent solid tumours

Roche’s personalised cancer therapy Rozlytrek (entrectinib) has seen its first approval: the drug has been approved in Japan for the treatment of neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours in both adult and paediatric patients, it has emerged.

As well as representing Rozlytrek’s first approval worldwide, the decision also marks the first authorisation of a tumour-agnostic medicine in Japan that targets NTRK gene fusions, which have implications in the treatment of a range of solid tumour types including pancreatic, breast, lung, c

Takeda scores Japanese Entyvio approval in Crohn's disease

Takeda has announced that Japan’s drug regulator, the Ministry of Health, Labour and Welfare (MHLW), has approved Entyvio (vedolizumab) in the treatment of moderately to severely active Crohn’s disease (CD).

The gut-selective biologic drug was originally launched in the country in November 2018, following approval for moderate to severe ulcerative colitis in July.

Novartis' Kymriah to be covered by Japan's national insurance system

Japan’s national medical insurance system will pay for Novartis’ CAR-T therapy Kymriah following approval from the Central Social Insurance Medical Council.

Kymriah, which costs 33.49 million yen ($305,455), will be covered by Japan’s national health insurance from the 22 May. Kymriah will thus become the most expensive treatment covered by Japan’s system.

Coverage will however be limited to leukaemia patients under the age of 25 who have failed to respond to other therapies.

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