Drug safety regulators are considering adding a warning that some diabetic therapies of DPP-4 inhibitor series can cause pemphigoid, a side effect in skin and subcutaneous tissue, to the conditions for their approval.
On Monday, the Ministry of Food and Drug Safety published changes in the approval conditions of two antidiabetic drugs – Boehringer Ingelheim Korea’s Trajenta (based on Linagliptin) and Takeda Pharmaceuticals Korea’s Nesina (based on alogliptin) – and is collecting opinions.
The new atypical response to be reflected on approval conditions this time is pemphigoid reported in Japan. It is a kind of autoimmune disease that forms a blister in the skin or mucous membranes.
According to Japan’s Pharmaceuticals and Medical Devices Agency, it has received seven reports of pemphigoid occurrences from Nesina, 14 from Tenelia, and 15 from Trajenta, and found it could not rule out a causal relationship in two cases of Nesina, seven cases of Tenelia and 10 cases of Trajenta. The Japanese agency judged these as atypical responses with clinical significance and had them reflected on warning message in November.
The Korean ministry also has decided to include pemphigoid in unusual reactions and add it to the approval conditions of Nesina and Trajenta. It will receive opinions on the revision until next March 28.
The ministry did not include Tenelia based on Teneligliptin in the list of drugs subject to the revision because the related process is already progressing in its maker, Handok.
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