Immune Therapeutics Files New Drug Application for Lodonol in Kenya to Target HIV Epidemic

Immune Therapeutics announced that the Kenya Pharmacy and Poison Board filed IMUN’s New Drug Application (NDA) for Lodonal, its lead drug candidate, thereby accepting the NDA for a full review.

Kenya is experiencing an HIV epidemic and currently has a reported 1.6 million people affected by HIV, many of which face high levels of discrimination.

“This is a very serious issue in Kenya and other parts of East Africa,” states CEO Noreen Griffin. “Everyone deserves access to compassionate and effective care and Immune Therapeutics is confident that once approved, our non-toxic immunotherapy Lodonal™ can have significant impact on the people and communities affected by the HIV epidemic.

Immune Therapeutics filed the application using the International Counsel for Harmonization Guidelines which was accomplished by incorporating the data complied in the white paper that was completed earlier this year. The ICH application is important as over 80 countries are participants in the ICH system.

“I am pleased to note that the acceptance of filing of our NDA for Lodonal™ represents a key achievement toward commercialization and impactful distribution of our lead drug candidate. We intend to work closely with Pharmacy and Poison Board as it reviews the NDA,” states Griffin.

Immune Therapeutics has been issued a confirmation number from the Pharmacy and Poison Board, so we can track our progress: GMP APP No.1272, site inspection and Product APP. No. 14514 and CTD 7365 for the following indication adjunct to the treatment of HIV and immune dysfunction.

“We look forward to Pharmacy and poison Board rendering a decision on approval for marketing of Lodonal during Q3 and Q4 2018.”