The biotechnology company Philogen S.p.A. has announced that the US FDA has awarded Orphan Drug status to Daromun for the treatment of stages IIb to IV melanoma. The original media statement can be read here, at Philogen.
About Melanoma
Melanoma is a form of skin cancer that originates in skin cells called melanocytes. It is thought to be the fifth most common cancer in the UK, and more than one in four cases are diagnosed in someone under the age of fifty, which is an earlier age than most other forms of cancer.
Research has linked melanoma to several risk factors, including sunburn, having many moles and freckles, pale skin, a family history of the disease, and naturally red or blonde hair.
About Daromun
Daromun is a drug that is being investigated as a possible treatment for melanoma at the stages IIb through to IV. It is made up of a combination of two proteins.
Orphan Drug Designation
The FDA has just awarded daromun Orphan Drug Designation. This status can be applied for if a drug is being developed as a treatment to a condition that is rare (defined as affecting fewer than 200,000 people in the United States), or that is not rare, but the company behind the drug do not expect to recover the money spent on developing and marketing it.
This designation is designed to support the drug developers and provide incentives for continued development. Drugs awarded Orphan Drug status are eligible for benefits including tax credits for clinical trials, and in some cases, waived prescription drug user fees.
Research into Daromun
According to the Philogen website, a Phase 2 study of daromun has shown the drug to be effective in patients with stage III/IVA melanoma. In some patients, it is reported to have led to complete and partial responses slowed progression to stage IV melanoma and led to a systemic immune response.
