HONG KONG – Japan’s Ministry of Health, Labour and Welfare (MHLW) ended the first half of 2020 by handing out a flurry of approvals to both domestic and international companies across a wide spectrum of indications.

“It is a relatively large number of approvals at one time, but the batch release of drug approvals is on an upward trend in Japan and other parts of the world,” Stephen Barker, equity analyst at Jeffries, told BioWorld. “There are a larger number of niche products being developed for relatively uncommon conditions.”

Eight companies received MHLW approvals for their drugs on June 30. They include the Incyte Corp.’s Tabrecta (capmatinib) for treating METex14 mutation-positive advanced and/or recurrent unresectable non-small-cell lung cancer; Novo Nordisk A/S’ Rybelsus (oral semaglutide), the first and only oral GLP-1 receptor agonist approved treatment for type 2 diabetes; and Rakuten Medical’s conditional early approval for ASP-1929 in treating recurrent head and neck cancer. Novartis AG received clearance for five products simultaneously: Tabrecta (in partnership with Incyte), Entresto (sacubitril valsartan sodium hydrate) for chronic heart failure, Mayzent (siponimod fumaric acid) for secondary progressive multiple sclerosis, Enerzair (in partnership with Sosei Heptares) for asthma, and Atectura (indacaterol acetate, mometasone furoate) also for asthma.

Others on the list include Roche Holding AG’s Enspryng (satralizumab), treating neuromyelitis optica spectrum disorder in adults as well as children; Teijin Pharma Ltd.’s marketing approval for Merz Pharmaceuticals GmbH’s Xeomin (incobotulinumtoxinA) intramuscular injections for treating upper limb spasticity; and Ono Pharmaceutical Co. Ltd.’s manufacturing and marketing approval for Ongentys (opicapone), cleared for treating end-of-dose motor fluctuations in Parkinson's disease in combination with levodopa- carbidopa or levodopa-benserazide hydrochloride.

Barker noted that Rakuten Medical’s approval, in particular, is “a significant milestone for [the company] and its Illuminox photoimmunotherapy platform.”

Novartis, meanwhile, has received seven new product approvals in Japan in 2020, including Zolgensma (onasemnogene abeparvovec), a spinal muscular atrophy treatment the MHLW cleared in March, as well as Beovu (brolucizumab), an anti-VEGF treatment for wet age-related macular degeneration.

“The simultaneous approval of five new products is remarkable for Japan and our industry,” said Kazunari Tsunaba, representative director and president of Novartis Pharma. “We are pleased to see that our innovative products have gained support from leading regulatory bodies.”

Meanwhile, Levi Garraway, Roche’s chief medical officer and head of global product development, stated that “today’s approval in Japan is the first for Enspryng (satralizumab) in Asia, providing a new treatment option to help reduce neuromyelitis optica spectrum disorder (NMOSD) relapses that cause irreversible disability, such as vision loss and paralysis.”

Garraway added that Japan has a high prevalence of NMOSD in both adults and children, but limited approved treatment options. Enspryng was shown to be effective and well-tolerated in clinical testing, and is the first and only approved therapy targeting the interleukin-6 (IL-6) receptor to be given subcutaneously every four weeks.

Not impeded by COVID-19 … so far

The MHLW told BioWorld that quarantine measures are currently in place so it could not provide further details on its string of approvals.

The Japanese government has lifted the state of emergency from Tokyo and four neighboring prefectures at the end of May; those regions were the last in the country to have the restrictions lifted. However, more than 100 COVID-19 cases were reported in Tokyo on Thursday, the highest in two months.

Although Jefferies’ Barker said that there is “no indication that [COVID-19] has affected the approvals process,” the country’s Chief Cabinet Secretary Yoshihide Suga warned during a July 1 press conference that the rising numbers could see the country declare a state of emergency for the second time.

He added, “The pandemic is affecting the conduct of clinical trials to some extent, particularly the recruitment of new subjects into trials and the launch of new trials, but [it seems that] the actual approvals process has not been impeded.”

The country was the first in the world to approve Gilead Science Inc.’s experimental drug, remdesivir, to treat COVID-19 in May. That proved the country was capable of fast tracking a drug.

The MHLW looks set for a busy third quarter as well, with many products submitted for approval by a wide range of companies, according to Barker.

A high-profile product likely to be approved for an additional indication this year is Astellas Pharma Inc.’s anemia treatment, roxadustat. It reported positive results in for its phase III DOLOMITES study for chronic kidney disease (CKD) patients undergoing regular renal dialysis in mid-June, and is gunning for the drug to receive approval later in the year for the additional indication of anemia in CKD patients who don’t require dialysis.

No Comments