FDA Accepts New Drug Application for Vascular Ehlers-Danlos Drug

According to a story by MarketScreener, pharmaceutical company Acer Therapeutics Inc. has submitted a New Drug Application (NDA) for its vascular Ehlers-Danlos syndrome (vEDS) drug Edsivo. The NDA was granted a priority review, a status granted to drugs that aim to treat a condition with no other equally effective treatment.

About Vascular Ehlers-Danlos Syndrome

Ehlers-Danlos syndrome is a group of disorders that mostly affect the body’s connective tissue; things like skin, tendons and ligaments, or the walls of your blood vessels. Vascular EDS is the most serious form of the disorder and can cause weakness in the body’s arteries – including the aorta.

Prognosis for vEDS patients is not always good – the median life expectancy for patients is some 48 years. There are as many as 2,000 individuals diagnosed with vEDS in the United States, though some believe the number of affected individuals might be closer to 5,000.

Currently treatment options are limited, though pharmaceutical companies continue to vie for a solution.

About Acer Therapeutics and Edsivo

Acer Therapeutics is a pharmaceutical company that focuses on the development and sale of orphan drugs. Orphan drugs are pharmaceuticals designed to treat a condition affecting fewer than 200,000 Americans. They got their name from their supposedly “undesirable” R&D costs, as the market of potential customers was long considered to be too small to garner any significant profit on the investment. However, the Orphan Drug Act of 1983 changed that for many pharmaceutical companies.

The Orphan Drug Act grants generous benefits to companies willing to chance the high-stakes risks associated with orphan drug development. Such benefits include various tax incentives, as well as a seven-year period of market exclusivity, when no company may advertise a competing drug for the same condition.

Despite the incentives, for many manufacturers orphan drugs are still too risky a venture to hazard. Others however, like Acer Therapeutics, wager their very bottom lines on the things. Edsivo is one such orphan drug, receiving its designation from the FDA back in 2015.

That’s right, four years on now and Edsivo’s “New” Drug Application has only just been submitted. This just goes to show the huge time frames associated with the development of these complex pharmaceuticals. Pending final FDA approval of the NDA, Edsivo’s seven-year marketing monopoly will kick into affect, and Acer will be cleared to market the drug in the United States. This has the potential to help hundreds of people across the country living with vascular type Ehlers-Danlos.


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