Shire plc SHPG announced that the FDA has granted fast track designation to Cinryze (intravenous administration) for antibody mediated rejection (AMR) in renal transplant recipients.
Shire is evaluating Cinryze as an adjunct treatment to donor specific antibodies (DSA) reduction therapy in kidney transplant patients with acute AMR.
Fast track designation from the FDA will facilitate the development and expedite the review of the drug for this indication. We note that the FDA generally grants Fast Track designation to those candidates that are being developed for the treatment of serious conditions with unmet medical need. Fast Track status will allow the company to communicate with the FDA frequently throughout the development process. Additionally, it will make the drug eligible for priority review if the required criteria are fulfilled.
Cinryze is currently approved for the treatment of routine prophylaxis against angioedema attacks in adolescent and adult patients suffering from hereditary angioedema (HAE). The drug was added to Shire’s portfolio following the acquisition of erstwhile ViroPharma in 2014. Cinryze complements Shire's Firazyr, which is indicated for the on-demand treatment of acute HAE attacks.
Meanwhile, Shire is planning to conduct a phase III study to evaluate the efficacy of intravenous administration of Cinryze as an adjunct to DSA reduction therapy (plasmapheresis, plasma exchange, and/or immune adsorption treatments and IVIG) for the treatment of acute AMR in kidney transplant recipients. This multi-center, randomized, double-blind, placebo-controlled trial will be conducted in the U.S., Europe and Canada.
The trial will be open for enrollment by end of the month.
Cinryze generated sales of $286.9 million in the first six months of 2015, up 33.1% from the year-ago period. A potential label expansion of the drug will boost its sales significantly.
Shire currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare space include Lannett Company, Inc. LCI, UCB SA UCBJF and AstraZeneca Plc AZN. All three stocks sport a Zacks Rank #1 (Strong Buy).
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