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Shire plc: CHMP Recommends EU Marketing Authorisation of lanadelumab for the Prevention of HAE Attacks | |||||||||||||||||||||||||||||
By: Nasdaq / GlobeNewswire - 19 Oct 2018 | Back to overview list |
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CHMP Recommends EU Marketing Authorisation of lanadelumab for the Prevention of HAE Attacks - If approved, lanadelumab would be the first monoclonal antibody for the preventive treatment of Hereditary Angioedema (HAE) available in the European Union Dublin, Ireland – 19 October 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG), the leading global biotechnology company focused on rare diseases, announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorisation of lanadelumab injection for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. If approved, lanadelumab will be a first-of-its-kind, fully human monoclonal antibody (mAb) available in the EU that inhibits the activity of plasma kallikrein, an enzyme which is uncontrolled in people with HAE, to help prevent attacks.1 HAE is a rare, genetic disorder estimated to affect about 1 in 10,000 to 1 in 50,000 people worldwide.2,3 The condition results in recurring attacks of oedema (swelling) in various parts of the body, including the abdomen, face, feet, genitals, hands and throat, that can be debilitating and painful. Laryngeal attacks that obstruct the airways are potentially life-threatening due to the risk of asphyxiation.2,4,5 “This positive opinion marks an important step towards providing adults and adolescents living with HAE in Europe a first-of-its-kind monoclonal antibody treatment option to help prevent attacks,” said Andreas Busch, Ph.D., Executive Vice President, Head of Research and Development at Shire. “We are excited about the future potential of lanadelumab in helping to address the needs of those living with this chronic and unpredictable disease.” The positive opinion is supported by data from the Phase III HELP (Hereditary Angioedema Long-term Prophylaxis) Study™, the largest randomised controlled prevention study conducted to date in HAE, which evaluated the efficacy and safety of subcutaneously administered lanadelumab versus placebo over 26 weeks in 125 patients 12 years of age or older with HAE.6 Lanadelumab was previously granted accelerated assessment by the EMA, reducing the number of evaluation days required from 210 to 150. The CHMP's positive opinion will be reviewed by the European Commission, which has the authority to grant marketing authorisation in the EU. Lanadelumab received approval for the prevention of HAE attacks in patient 12 years and older in the U.S. on 23 August 2018 and Canada on 19 September 2018, under the brand name TAKHZYRO™.1,7 Supportive Data The primary endpoint of the HELP Study™ was the number of investigator-confirmed HAE attacks over the entire 26-week study duration. Lanadelumab demonstrated that subcutaneous injections every two or four weeks reduced the mean monthly number of attacks across all three lanadelumab treatment arms studied: 300 mg every two weeks, 300 mg every four weeks, and 150 mg of lanadelumab every four weeks. At 300 mg every two weeks, lanadelumab reduced the number of mean monthly HAE attacks by 87% vs. placebo (adjusted P<0.001).6 Overall, each lanadelumab treatment arm demonstrated statistically significant attack rate reductions compared with placebo for all secondary efficacy endpoints (adjusted P<0.001 for all comparisons). Patients taking lanadelumab 300 mg every 2 weeks had 83% fewer moderate or severe attacks and 87% fewer attacks that needed on-demand treatment. A pre-specified, exploratory analysis showed that 44% of patients (n=27) receiving lanadelumab 300 mg every two weeks had zero attacks compared to placebo (2%, n=41) for the 26-week treatment period.1 Additionally, in a post hoc sensitivity analysis of the steady state period from Day 70 to Day 182, 77% of patients (n=26) treated with lanadelumab in the same dosage arm of the trial were attack-free compared to placebo (3%, n=37).8 Relevant Safety Information from the HELP Study™ About lanadelumab For full U.S. and Canada Prescribing Information, including the approved indications and important safety information, please visit US Prescribing Information and the Canadian Product Monograph. Shire’s Commitment to Hereditary Angioedema For further information please contact:
NOTES TO EDITORS About Shire Shire is the global biotechnology leader serving patients with rare diseases and specialised conditions. We seek to push boundaries through discovering and delivering new possibilities for patient communities who often have few or no other champions. Relentlessly on the edge of what’s next, we are serial innovators with a diverse pipeline offering fresh thinking and new hope. Serving patients and partnering with healthcare communities in over 100 countries, we strive to be part of the entire patient journey to enable earlier diagnosis, raise standards of care, accelerate access to treatment, and support patients. Our diverse portfolio of therapeutic areas includes Immunology, Haematology, Genetic Diseases, Neuroscience, Internal Medicine, and Ophthalmics. Forward-Looking Statements Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, projected revenues, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products, are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:
a further list and description of risks, uncertainties and other matters can be found in Shire’s most recent Annual Report on Form 10-K and in Shire’s subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in “ITEM1A: Risk Factors”, and in Shire’s subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire’s website. All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise. 1 TAKHZYRO™ (lanadelumab-flyo) injection prescribing information. Lexington, MA: Shire LLC; 2018.
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Copyright 2018 Nasdaq / GlobeNewswire | Back to overview list |