Medicus Pharma, a pharmaceutical company focused on developing innovative therapies, has recently received valuable feedback from the U.S. Food and Drug Administration (FDA) concerning its investigational product, D-MNA. The FDA’s comments pertain to the company’s recent study findings and regulatory submissions.
According to Dr. Raza Bokhari, Executive Chairman and CEO of Medicus Pharma, the FDA has requested additional data from clinical studies to support the doses of 100μg and 200μg of micro-array needles containing doxorubicin. Furthermore, the agency has requested an updated investigator brochure, incorporating insights from the clinical studies SKNJCT-001 and SKNJCT-002, with a particular focus on adverse events and dose-limiting toxicities at each dose level.
Dr. Bokhari highlighted that the SKNJCT-001 study successfully met its primary objective of assessing the safety and tolerability of D-MNA. The investigational product demonstrated favorable safety profiles across all dose levels among the thirteen participants enrolled in the study. This encouraging outcome underscores the potential of D-MNA as a safe and well-tolerated therapeutic option.
In response to the FDA’s requests, Medicus Pharma is committed to making a comprehensive submission in the second quarter of 2024. This submission will include the requested data, an updated investigator brochure meticulously incorporating insights from the SKNJCT-001 and SKNJCT-002 studies, and Chemistry, Manufacturing, and Controls (CMC) stability data, ensuring a robust dossier.
Dr. Bokhari reiterated Medicus Pharma’s dedication to adhering to regulatory guidelines and fostering transparent communication with regulatory authorities. By addressing the FDA’s queries and providing comprehensive data, the company aims to facilitate the regulatory review process and advance the development of D-MNA towards potential regulatory approval.
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