CDSCO panel rejects Optimus Pharma Phase III CT protocol of Tofacitinib Ointment for androgenic alopecia
New Delhi: Citing that there is no scientific rationality data and supportive published literature, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has rejected Optimus pharma's proposal of Phase III clinical trial protocol of Tofacitinib Ointment 2% w/v for androgenic alopecia.
Furthermore, the expert panel opined the drug maker Optimus Pharma to submit pre-clinical data, published clinical data and scientific rationality with respect to Tofacitinib Ointment 2% w/v for androgenic alopecia.
Androgenetic alopecia is a common form of hair loss in both men and women. Androgenic alopecia can be caused by a variety of factors tied to the actions of hormones, including some ovarian cysts, taking high androgen index birth control pills, pregnancy, and menopause. Recently, JAK inhibitors have been considered for treatment of other types of hair loss, such as androgenetic alopecia.
Tofacitinib is a non-FDA approved treatment for hair loss secondary to alopecia areata. This Janus kinase inhibitor (JAK inhibitor) interferes with the immune system to prevent the autoimmune disease alopecia areata. Tofacitinib encourages hair regrowth and healthy hair follicles.
The inhibition of JAKs can simultaneously block the function of multiple cytokines. Therefore, JAK inhibitors are emerging as a new class of drugs, which in dermatology can either be used systemically as oral drugs or locally in topical formulations.
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