Japan
A shifting political power balance in Japan is leading to renewed debate on the pace of regular drug reimbursement price cuts.
Formal full official approvals for both products expected by early January, which would in both cases be the first to be granted worldwide.
A new batch of positive approval recommendations in Japan includes an ALS drug requested by a local patient group.
While Japan awarded relatively high premiums to several products newly listed for reimbursement, others were the subject of prolonged debate or are facing imminent cost-effectiveness assessment.
Japan has granted an initial reimbursement price for Kisunla slightly above that for Alzheimer's rival Leqembi, but is holding out the prospect of future price revisions.
Japan has implemented a streamlined regulatory system designed to enable speedier approvals of selected drugs for designated categories of infectious diseases, which does not require Japanese clinical data.
Along with several new positive approval recommendations, Japan's proceeding to grant Sakigake designation to two drugs including a DMD gene therapy discovered through public collaboration. Meanwhile, the PMDA has opened a new full-time office in the US.
Japan is cautiously easing Japanese clinical data requirements for rare disease drugs to allow faster and more flexible approvals, including on a conditional basis supported by postmarketing studies.
Dispute around the first-in-world license for a self-amplifying mRNA COVID-19 vaccine castes light on Japan’s ongoing dilemma between a government trying to build its own capabilities to attract, develop and manufacture new modalities and the anti-vax movement in the country.
Japan has started to charge patients a portion of the difference between the reimbursement price of the generic and non-generic product if they insist on the latter without a supporting recommendation from the prescribing physician, in a policy designed to further drive generic use.
Japan plans to offer wider support to foreign firms and ventures with innovative candidates to start clinical trials in the country, as part of key measures from current prime minister Fumio Kishida.
Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.
The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
Japan has issued positive approval recommendations for 10 new drugs, including Catalyst’s Firdapse and Idorsia/Nxera’s Quviviq, as well as a global-first nod for mecobalamin in ALS.
The deadline is nearing for pharmacopoeias to express their interest in joining the decades-old discussion group that works to harmonize excipient monographs and general chapters and reduce the burden on manufacturers to perform analytical procedures in different ways depending on the jurisdiction.
The country is aiming to tighten collaboration with Asian authorities and share globally its knowledge and experience of universal health coverage systems globally and will open a joint office in Tokyo with the WHO and World Bank in 2026.
After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting reimbursement prices. How has the sector panned out over the last decade?
A Japanese approval for Lilly's Alzheimer's drug donanemab is expected soon following a positive recommendation from the MHLW. The ministry has also announced reimbursement prices for 12 new products including Fabhalta, along with price cuts for Tezspire, Dupixent and competitors following a review.
Despite it’s initial promise, a novel autologous cell transplant therapy for severe heart failure has faced multiple challenges gaining full approval in Japan, potentially offering lessons for other regenerative medicine developers.
England’s NICE has “misclassified” HER2-low metastatic breast cancer as a medium severity disease, say AstraZeneca and Daiichi Sankyo, the co-developers of Enhertu. NICE said it would consider a rapid re-appraisal if the companies offered a “fair price” for the drug.