KINGSTON, Jamaica — A drug developed by Jamaican scientist Dr Henry Lowe and his team of researchers to treat acute myeloid leukemia (AML), has been granted orphan-drug designation by the United States Food and Drug Administration (FDA).

News of the development was made public a short while ago by Dr Lowe who described it as historic and said it holds the potential to earn Jamaica more than US$250 million within three years in the US market alone.

“As far as I am aware, this is the first time that anyone from a developing country like Jamaica has been able to achieve this feat of starting from the isolation of a bioactive molecule and working it up to provide a new drug from scratch, which is recognised by the FDA, which is the world leading food and drug regulator and approval agency,” Lowe told guests at a function at his Eden Gardens Wellness Resort and Spa in Kingston.

Lowe, known for using the properties of Jamaican plants, particularly ball moss and cannabis, in his cancer research, was notified of the approval last month.

The FDA, in a letter to Flavocure Biotech, a company formed by Dr Lowe, stated that it was granting the company’s request for the drug to be designated orphan drug status pursuant to section 526 of the Federal Food, Drug, and Cosmetic Act.

Significantly, the FDA stated that the designation granted is broader then the indication proposed in the company’s request.

The FDA explains on its website that the Orphan Drug Act (ODA) provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor.

“This status is referred to as orphan designation (or sometimes “orphan status”). For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDA’s implementing regulations,” the agency states.

This afternoon, Dr Lowe explained that the drug, which has the trade name Cresorol, is a non-cannabinoid developed from the cannabis plant.