Japan’s Sakigake Approval Pathway Aims to Cut Drug Lag, Expert Says

Japanese regulators are hoping to halve drug review times and speed up patient access to novel therapies by encouraging companies to file NDAs first in Japan, or in tandem with U.S. and EU submissions, under an approval pathway approved in April.

To utilize the pathway — known as Sakigake — drugmakers must file NDAs with Japan’s Pharmaceuticals and Medical Devices Agency at specified times during the year and must be able to show, with nonclinical and early clinical studies, that their candidates show promise of radically improving existing treatments, says Alberto Grignolo, corporate vice president for global strategy and services at Parexel. If not a first-in-Japan filing, it must be within a month of FDA or European Medicines Agency submissions.

The aim, Grignolo explains, is to cut review times from 12 months to six, increase the number of Japanese patients in clinical trials and spur innovation in a country where many top-selling U.S. drugs see market delays of more than two years. He discussed Sakigake during an FDAnews webinar.

The process consists of a de facto presubmission review, followed by submission of the NDA, a one-month consultation, formal review and acceptance of Phase 3 data. Requests to use Sakigake must be made to the PMDA’s evaluation and licensing division and will be acknowledged within 60 days.

Grignolo suggests sponsors look at their treatment pipelines to see if any drug or biological candidates would meet the timeline criteria. Since there are strict deadlines (this year’s was May 29, but next year’s deadlines haven’t been set), firms should pay attention to when the next chance to file will be and apply for Sakigake at the next available opportunity. Applications in other jurisdictions would need to work around the Japanese timeline rules.

Drugmakers should also be aware that the common technical document used to submit a new drug for review in Japan is very different from that of the FDA and prioritize the quality overall summary over the quality data sections, since that is given more weight in PMDA reviews.

So far, about 60 drugs have been submitted for Sakigake review, 51 of which passed an initial PMDA screening, Grignolo says. Five to 10 of those will be granted Sakigake late this month, he adds. — Victoria Pelham

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