Markets

Shire's Cinryze Gets Fast Track Status for Additional Indication

An image of multiple stacks of coins
Credit: Shutterstock photo

Shire plcSHPG 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).

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

UCB SA (UCBJF): Free Stock Analysis Report

ASTRAZENECA PLC (AZN): Free Stock Analysis Report

SHIRE PLC-ADR (SHPG): Free Stock Analysis Report

LANNETT INC (LCI): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

In This Story

UCBJF AZN LCI

Other Topics

Stocks

Latest Markets Videos

Zacks

Zacks is the leading investment research firm focusing on stock research, analysis and recommendations. In 1978, our founder discovered the power of earnings estimate revisions to enable profitable investment decisions. Today, that discovery is still the heart of the Zacks Rank. A wealth of resources for individual investors is available at www.zacks.com.

Learn More