Dyax Hereditary Angioedema Drug Gets Breakthrough Status - Analyst Blog
Dyax Corp. DYAX announced that the FDA has granted Breakthrough Therapy designation to its fully human monoclonal antibody inhibitor of plasma kallikrein, DX-2930, being developed as a subcutaneous injection for the prevention of hereditary angioedema (HAE) attacks.
We note that Breakthrough Therapy designation is granted by the FDA to expedite the development and review of a candidate that is believed to have the potential to treat a serious or life-threatening disease or condition and which may show substantial improvement over existing therapies on the basis of preliminary clinical evidence. Additionally, Breakthrough Therapy status makes the candidate eligible for certain benefits including access to the FDA's senior managers and more intensive guidance from the agency. However, this designation does not alter the standards for marketing approval of the candidate.
Earlier this year, the company had announced positive results from a phase Ib study on DX-2930. The candidate met all its primary objectives including safety, tolerability and pharmacokinetics. Given the data, the company intends to move the candidate into the next stage of development pending discussions with the FDA.
We are encouraged by the FDA granting Breakthrough Therapy designation to DX-2930, which will expedite its development process. According to the press release issued by the company, HAE is estimated to affect about 1 in 50,000 people. The candidate also enjoys Fast Track and orphan drug status in the U.S.
We note that Dyax’s only approved product, Kalbitor is approved in the U.S. for the treatment of acute attacks of HAE in patients aged 12 years and above. Apart from this, other prescribed treatments for HAE include Shire’s SHPG Firazyr and Valeant Pharmaceuticals International, Inc.’s VRX Ruconest.
Dyax currently holds a Zacks Rank #4 (Sell). AMAG Pharmaceuticals, Inc. AMAG is a better-ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).
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