US agency accepts plan for Ugandan pharmaceutical company's two new drugs

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Uganda-based Dei BioPharma Ltd says the US Food and Drug Administration (FDA) has accepted its development plan for two novel biological drugs developed by its scientist, Dr Matthias Magoola.

The two drugs, which the firm also plans to distribute globally at an affordable price after FDA’s approval, are liraglutide (Victoza) and semaglutide (Ozempic).

These drugs are part of a powerful new class of medications that has taken the world by storm, known as glucagon-like peptide 1 or GLP-1 receptor agonists. Originally developed to treat type 2 diabetes, they proved to be highly effective at helping people shed weight in clinical trials. 

In order to approve a drug, the FDA must determine that the research and data submitted by the sponsor show that the drug is safe and effective for the intended use. 

It emerged on August 21, 2025, that on August 7, the FDA issued a written notification agreeing 100% with Dei BioPharma’s plan for the FDA submission.

“Dei BioPharma projects to earn revenue of $15b per year from these products once launched,” the company, which is now filing for the products’ approval, said in a statement yesterday.

“Our promise of making biological drugs affordable to the rest of the world is coming to fruition,” Magoola told New Vision Online.

Dei BioPharma said the first patented platform is a universal messenger RNA (mRNA) cancer vaccine designed to convert “cold,” immune-invisible tumours into “hot,” immune-responsive targets.

Unlike conventional cancer vaccines that require patient-specific customisation, the firm said this vaccine uses non-tumour-specific antigens encapsulated in lipid nanoparticles to stimulate type-I interferon responses, triggering widespread immune activation.

The firm said preclinical trials have shown remarkable efficacy, including complete tumour regression and up to 90% protection against recurrence.

It explained that the vaccine’s ability to induce epitope spreading enables the immune system to recognise multiple tumour markers simultaneously, and it demonstrates strong synergy with checkpoint inhibitors such as anti-PD-1 therapies.

“This innovation, protected by a patent filed in the U.S., positions Dei BioPharma as a global leader in immune reprogramming and cancer immunotherapy," the firm said.

Dei BioPharma says its goal is not only to revolutionise how diseases are treated but also to ensure that these therapies reach patients everywhere—from elite hospitals in developed nations to rural clinics across Africa and the Global South.

NDA hails Magoola

National Drug Authority (NDA) chairperson Dr Medard Bitekyerezo commended Magoola for the inventions in a recent interview with New Vision Online.

“I want to salute Magoola for being a brave man and venturing into producing rare and expensive drugs in the country. I am happy he is working through collaborations with the US drug manufacturers to manufacture the same drugs here using their active pharmaceutical ingredients,” he said.

Bitekyerezo said as NDA, they would be glad to walk the journey of fully producing this cancer treatment drug with Magoola so that Ugandans can stop buying drugs from outside the country. Ends

“For us as NDA, we support Magoola and we hope he will start producing drugs as soon as possible because Ugandans have been put into an expectant mood. They want to see us start producing these vaccines,” he said.