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Blog Exposure - Shire Gets BLA and Priority Review Status from FDA for Lanadelumab for the Prevention of HAE Attacks

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LONDON, UK / ACCESSWIRE / February 26, 2018 / Active-Investors.com has just released a free research report on Shire PLC (NASDAQ: SHPG). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=SHPG as the Company's latest news hit the wire. On February 23, 2018, the global specialty biopharmaceutical Company declared that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted priority review for Lanadelumab (SHP643), which is its investigational monoclonal antibody for treatment of Hereditary Angioedema. Register today and get access to over 1,000 Free Research Reports by joining our site below:

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Hereditary Angioedema - A Debilitating Condition

Hereditary Angioedema (HAE) is a rare, genetic disorder, which instigates debilitating, painful and life-threatening swelling in the body. HAE causes recurring attacks of edema or swelling in various parts of the body such as the abdomen, face, feet, genitals, hands and throat. Of these, the attacks that obstruct the airways (asphyxiation) are potentially life threatening. HAE causes a lot of suffering to patients – on an average, HAE patients take 20 days away from school or off from work per year.

Lanadelumab for Treatment of HAE Patients

Lanadelumab is an investigational fully human monoclonal antibody that binds and inhibits plasma kallikrein. The drug is prepared for subcutaneous administration and has a half-life of approximately 14 days in patients with HAE. Currently, Lanadelumab is being evaluated as a treatment option for the prevention of angioedema attacks in patients 12 years and older, suffering with HAE.

If approved, Lanadelumab will be the first monoclonal antibody for HAE. The drug offers a new alternative to patients to overcome this disease, with the potential to change the treatment paradigm.

BLA Based on Recent Clinical Trials

FDA's BLA for Lanadelumab is based on the data from four clinical trials, including the HELPTM and interim data from its extension study.

HELPTM was the pivotal Phase-3 efficacy and safety study that enrolled a total of 125 patients aged 12 years and over with type I/II HAE. It was the largest prevention study in HAE conducted till date.

Results from the HELP study showed that subcutaneous administration of 300 mg Lanadelumab once every two weeks led to an 87% reduction in the mean frequency of HAE attacks. Moreover, an exploratory endpoint, which would require additional confirmatory studies, proved that during the steady state stage of the trial, i.e. day 70-182, attacks were reduced by 91% in 8 out of 10 patients, thus reaching an attack free state. In addition, there were no treatment-related serious adverse events or deaths reported in the study. The most common adverse event reported was injection site pain, 29.3% in placebo versus 42.9% in combined Lanadelumab arms.

Implications of the Priority Review Status

The FDA awards Priority Review designation to only those drugs that have potential to provide noteworthy improvements in the safety or effectiveness for the treatment, diagnosis or prevention of a serious disease. Drugs that get a Priority Review status are entitled to have an accelerated review target of eight months, as compared to the standard period of 12 months. As per the Prescription Drug User Fee Act V action date, the FDA is expected to provide a decision on Lanadelumab by August 26, 2018.

FDA's Approval Underscores Shire's Commitment towards HAE Community

Shire has been a dedicated, long-term partner to the HAE community for the past decade. The Company's existing portfolio includes several therapy options to meet the needs of appropriate patients with HAE. Apart from developing novel treatments, Shire also offers specialized services and support offerings for the HAE community. Aleena Banerji, M.D., Massachusetts General Hospital, Boston, Massachusetts, and clinical trial investigator shared that physicians as well as patients in the HAE community are thrilled to see Lanadelumab moving forward for FDA review since it signifies real possibility of having a new way to prevent HAE attacks.

FDA's recent approval for Lanadelumab highlights Shire's serial innovation in HAE and its commitment towards enhancing treatment options for patients. Besides, Lanadelumab's BLA acceptance also strengthens Shire's leadership in rare disease innovation. The Company has a global approach to rare disease drug development. Shire has been awarded the Priority Review and Orphan Drug Designation from the Therapeutic Goods Administration in Australia and Priority Review from Health Canada for review of Lanadelumab. In fact, the specialty pharmaceutical Company received Breakthrough Therapy, Orphan Drug or Fast Track designations by the FDA for five of its rare disease therapies in 2017. Looking forward, Shire expects continued progress of its late-stage programs on key regulatory milestones.

Stock Performance Snapshot

February 23, 2018 - At Friday's closing bell, Shire's stock was slightly up 0.82%, ending the trading session at $127.08.

Volume traded for the day: 918.34 thousand shares.

After last Friday's close, Shire's market cap was at $38.45 billion.

Price to Earnings (P/E) ratio was at 20.95.

The stock has a dividend yield of 0.83%.

The stock is part of the Healthcare sector, categorized under the Drug Manufacturers - Major industry. This sector was up 1.4% at the end of the session.

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