MSN Laboratories gets CDSCO Panel nod to conduct Bioequivalence Study of Abiraterone Tablets1000mg
New Delhi: MSN Laboratories has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct a bioequivalence study of the anti-cancer drug Abiraterone Acetate film-coated tablets 1000mg.
This came after MSN Laboratories presented the proposal for a grant of permission for the manufacture and marketing of Abiraterone Acetate film-coated tablets, 1000 mg, along with the bioequivalence protocol and justification for waiver of the Phase III clinical trial before the committee.
The firm has informed that CDSCO has already approved the lower strength of Abiraterone Acetate 250mg and 500mg for applied indication in the years 2011 and 2018 in the country.
Further, the firm has informed that the proposed formulation of Abiraterone Acetate tablets 1000mg is already approved in Europe in the year 2021.
Abiraterone is an antiandrogen used in the treatment of metastatic castration-resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer. Abiraterone is a potent, irreversible, and selective inhibitor of 17 αhydroxylase/C17,20-lyase (CYP17), an enzyme expressed in testicular, adrenal, and prostatic tumor tissues, to regulate androgen biosynthesis. Abiraterone inhibits CYP17 to block androgen production. Inhibition of CYP17 can also result in increased mineralocorticoid production by the adrenals.
At the recent SEC meeting for Oncology held on 9th July 2024, the expert panel reviewed the proposal for grant of permission for the manufacture and marketing of Abiraterone Acetate film-coated tablets 1000mg along with bioequivalence protocol and justification for waiver of Phase-III clinical trial before the committee.
After detailed deliberation, the committee recommended for the grant of permission to conduct a bioequivalence study as per the protocol presented by the firm.
Furthermore, the expert panel suggested that the firm should submit a bioequivalence study (BE study) report along with clinical data to CDSCO for further consideration by the committee.
