Japan Faces GLP-1 Shortage As Off-Label Diet Use Surges

Grey Areas Between Regulations

Despite repeated warnings by regulatory authorities and physicians’ associations, the demand for easy diet aids is impacting the supply of GLP-1 receptor antagonists in Japan.

The shortage suffers legal dilemma of off label use of drugs or use of unapproved drugs.
Japan GLP-1 shortages grow due to legal grey area of off-label use • Source: Shutterstock

Japan is facing a supply shortage of GLP-1 receptor antagonists for type 2 diabetes due to their off-label use as diet drugs, prompting the main manufacturers to restrict supplies and calls for their use only in officially approved indications.

More from Japan

Japan Pushes Generic Industry Reforms Via New Govt Fund

 
• By 

Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.

Japan Expands Priority R&D List For Regular Vaccinations

 
• By 

Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.

Japan Recommends Beyonttra, Raises Enhertu Price

 
• By 

Japan recommends eight new drugs for approval, including two for cardiomyopathy, and will also raise prices for multiple products, including Enhertu, on 1 April.

Japan PM Delays Revision Of High-Cost Healthcare Benefit After Patient Protests

 
• By 

A plan to reduce benefits under Japan's financial safety net for patients contributing to the costs of their long-term medical care is being reconsidered by the government following protests from patient and doctor groups.

More from Asia

Japan Expands Priority R&D List For Regular Vaccinations

 
• By 

Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.

Elevar/Hengrui’s Second US CRL A Bad Omen For Multiregional Trials In Asia-Dominant Cancers?

 

While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.

China Signals Commercial Insurance, Biotech And Foreign-Owned Hospitals As Policy Priorities

 
• By 

The main 2025 policy priorities for China's government as outlined in an annual report will include the strengthening of commercial insurance for innovative drugs and opening up cell and gene therapy and the hospital sector to foreign investment.