Akcea Therapeutics Inc (NASDAQ:AKCA) is gaining slightly today, currently up 53 cents at $23.36 in mid-afternoon trading – a 2.3 percent increase from yesterday’s closing price of $22.83. After the market close yesterday, the drug maker announced that it had officially filed a New Drug Submission (NDS) to Health Canada for its familial chylomicronemia syndrome (FCS) therapy.
The drug, called volanesorsen, is an investigational treatment developed in collaboration with Ionis Pharmaceuticals Inc (NASDAQ:IONS). Luckily for these two pharmaceutical partners, volanesorsen has already been given priority review by Health Canada – which will fast track its regulatory review.
Paula Soteropolous, Akcea’s President and Chief Executive Officer, told shareholders in the press release announcing the NDS filing that she is “pleased” with the company’s third worldwide regulatory filing for the drug.
“We are also pleased that Health Canada has granted priority review for the volanesorsen NDS for the treatment of FCS in Canada, which could accelerate access to this important new medicine for Canadians suffering with FCS,” said Soteropolous. “With regulatory filings for marketing authorization for volanesorsen submitted in the U.S., EU and now Canada, we are on track for a potential global commercial launch of volanesorsen in 2018.”
FCS is a serious and very rare condition known for patients experiencing elevated levels of triglycerides, which cause symptoms like abdominal pain that impact their day-to-day lives – along with the risk of recurrent, and possibly deadly, acute pancreatitis. The heightened triglyceride levels are due to a deficiency of ipoprotein lipase.
These patients cannot properly break down triglycerides, which causes their levels to grow to between 20 and 30 times the triglycerides of healthy patients. At the moment, there are no currently-approved drugs commercially available that effectively treat FCS.
The author of this article holds no position in any of the companies mentioned above.