An Australian company has won unprecedented approval from the United-States Food and Drug Administration for a new drug to treat the second-most-common preventable cause of blindness in the world – river blindness.
The current treatment is 20 years old.
The company, Medicines Development for Global Health, based in Melbourne, has become the first not-for-profit company in the world to register a medicine with the US FDA.
Managing director of the company, Mr Mark Sullivan, said while FDA approval for the company’s drug, moxidectin, was a “momentous achievement” for any pharmaceutical company, it was “a particularly rare and exciting event” for those trying to treat neglected diseases.
The FDA gave its approval for the treatment, which is swallowed as a tablet, in June after the application was submitted in October 2017.
Mr Sullivan established the Melbourne-based not-for-profit company in 2005 with the sole purpose of filling the gap left by the big pharmaceutical companies by developing medicines that were based on need for treatment rather than the patients’ ability to afford them.
His company has been working for five years on the development of the drug and is now planning to develop it as a new treatment for scabies, a common problem in indigenous communities.
Priority review voucher scheme
The company has also won a priority review voucher under a scheme set up in 2007 to create a financial incentive to reward drug manufacturers willing to spend the time and money developing treatments for the some of the world’s most neglected diseases. The scheme creates a market for making new drugs that the private market was not filling itself.
Under the scheme, a company that wins a voucher gets a fast track through the FDA for consideration of its next new drug, even if it’s a treatment that would have a commercial return. That gives it a head-start over rivals.
Crucially, a company can also sell the voucher to a bigger company willing to pay anywhere between $US100 million and $300 million for the right to almost halve the approval time.
Because Medicines Development for Global Health is a not-for-profit, its proceeds from drug sales and the voucher will be reinvested in the company to develop new drugs for other neglected diseases.
“Our plan is to sell the voucher and use the funds to support further development of moxidectinfor other neglected diseases but also to expand our portfolio into other medicines and vaccines,” Mr Sullivan said.
Professor David Ridely from Duke University authored the scheme and said Medicines Development for Global Health was a textbook example of how he envisaged the program would work.