Dr. Reddy's gets CDSCO panel nod to study Fosravuconazole L Lysine Ethanolate Capsule
New Delhi: Granting the waiver of bioequivalence study, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has given its nod to pharmaceutical major Dr. Reddy's Laboratories to conduct a Phase III clinical trial of Fosravuconazole L-Lysine Ethanolate Capsule169.1 mg.
This came after Dr. Reddy Lab presented their proposal along with the Phase III clinical trial protocol and justification for bioequivalence study waiver before the committee.
Fosravuconazole L-lysine ethanolate is a prodrug of ravuconazole, a novel triazole antifungal agent. It exerts broad and potent antifungal activity.
Ravuconazole is a fourth-generation azole exerting strong antifungal activity. It has low drug-drug interaction and hepatic dysfunction risks.
The pharmacokinetic properties get improved and bioavailability after oral administration reaches 100% when converted to a prodrug. Fosravuconazole l-lysine ethanolate was developed as a ravuconazole prodrug.
The plasma ravuconazole concentration became 10-35 times higher than with current oral anti-onychomycosis drugs, and showed good skin and nail tissue transition plus tissue retention.
Fosravuconazole L-lysine ethanolate can be used for candidiasis, onychomycosis, and parasitemia research. It is an orally active broad-spectrum antifungal agent.
Fosravuconazole has potent in vitro antifungal activity against a wide range of fungal species, including Candida, Aspergillus, and Trichophyton species. Ravuconazole and its prodrug, fosravuconazole L‐lysine ethanolate, are newly developed oral antifungal agents.
The mechanism underlying the antifungal activities of Ravuconazole is the inhibition of ergosterol biosynthesis. This activity is potently exerted against a broad spectrum of dermatophytes and pathogenic fungi, including the genera Trichophyton, Candida, Aspergillus, and Cryptococcus.
Fosravuconazole L‐lysine ethanolate demonstrates significantly higher efficacy and sufficient tolerability when administrated to patients with onychomycosis.
At the 68th SEC meeting for Dermatology & Allergy held on 19.04.2022, the expert panel reviewed the proposal presented by the drug maker Dr. Reddy's Laboratories along with the Phase III CT protocol and justification for BE study waiver in detail.
After detailed deliberation, the committee agreed to the waiver of BE study and recommended the grant of permission to conduct the Phase III CT as per the proposed protocol.
