Subject: FDA
Allergan Announces FDA Approval Of RHOFADEtm (Oxymetazoline Hydrochloride) Cream, 1% For The Topical Treatment Of Persistent Facial Erythema Associated With Rosacea In Adults
DUBLIN, Jan. 19, 2017 /PRNewswire/ -- Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, announced today the approval of RHOFADEtm cream by the U.S. Food and Drug Administration (FDA) for the topical treatment of persistent facial erythema (redness) associated with rosacea in adults. Approval was based on two clinical studies that evaluated the primary efficacy endpoint on day 29.1
"The FDA approval of RHOFADEtm exemplifies Allergan's commitment to continuing to address unmet patient needs through innovation in medical dermatology," said David Nicholson, Chief R&D Officer of Allergan plc. "We know persistent facial erythema associated with rosacea is a challenge for patients and physicians and having options can help in treating the disease. RHOFADEtm is the first and only alpha1A adrenoceptor agonist approved for persistent facial erythema associated with rosacea in adults. The FDA approval of RHOFADEtm represents a new prescription treatment that can effectively help physicians and their patients manage this condition."
The National Rosacea Society (NRS) estimates that approximately 16 million Americans are affected by rosacea.2 Persistent facial redness is cited as the most common sign of rosacea, and may resemble a flushing or sunburn that does not go away.3 Typical triggers include sun exposure, stress, weather, food, exercise and/or products.4 In an NRS survey, 65% of rosacea patients surveyed said their symptoms first appeared between 30-60 years of age.5
"Historically, there haven't been many options available to help physicians address persistent facial erythema and often we ended up just helping our patients identify and manage triggers, which can lead to frustration for both the doctor and patient," said Dr. Robert Weiss, Clinical Trial Investigator and Director of Maryland Laser, Skin & Vein Institute. "With the approval of RHOFADEtm, doctors will now be able to provide their patients with an effective once-daily treatment option to help manage this condition."
In two clinical trials, a once-daily application of RHOFADEtm was proven to reduce persistent facial erythema associated with rosacea through 12 hours. The primary efficacy endpoint was at day 29 and defined as the proportion of patients with at least a 2-grade reduction in erythema (improvement) from baseline (pre-dose on day 1) on both the clinician erythema assessment (CEA) and subject self-assessment (SSA) (composite success) measured at hours 3, 6, 9 and 12 versus vehicle. CEA and SSA also measured at Days 1 and 15 at hours 3, 6, 9, and 12.1
The clinical trials were identical, multicentered, randomized, double-blind, parallel-group, and vehicle-controlled in moderate or severe patients, N=885, 18 years or older.1
In both pivotal trials, the primary efficacy endpoint was met. The proportion of patients achieving composite success were as follows: at hours 3, 6, 9 and 12 results in study 1 were RHOFADEtm (N=222) 12%, 16%, 18%, 15% versus Vehicle (N=218) 6%, 8%, 6%, 6% and in study 2 were RHOFADEtm (N=224) 14%, 13%, 16% and 12% versus Vehicle (N=221) 7%, 5%, 9% and 6%. RHOFADEtm was proven more effective than vehicle in reducing persistent facial erythema associated with rosacea in adults.1
RHOFADEtm will be available for commercial supply starting May 2017 in the United States. For more information, visit www.Rhofade.com.
RHOFADETM (oxymetazoline hydrochloride) cream, 1% Indication and ISI
Indication
RHOFADETM (oxymetazoline hydrochloride) cream, 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS"
Potential Impacts on Cardiovascular Disease
Alpha-adrenergic agonists may impact blood pressure. RHOFADETM should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension to seek immediate medical care if their condition worsens.
Potentiation of Vascular Insufficiency
RHOFADETM should be used with caution in patients with cerebral or coronary insufficiency, Raynaud's phenomenon, thromboangiitis obliterans, scleroderma, or Sjögren's syndrome. Advise patients to seek immediate medical care if signs and symptoms of potentiation of vascular insufficiency develop.
Risk of Angle Closure Glaucoma
RHOFADETM may increase the risk of angle closure glaucoma in patients with narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute angle closure glaucoma develop.
ADVERSE REACTIONS
The most common adverse reactions for RHOFADETM were: application site dermatitis 2 %, worsening inflammatory lesions of rosacea 1%, application site pruritus 1%, application site erythema 1%, and application site pain 1%.
Please see accompanying RHOFADETM full Prescribing Information.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model ? Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 16,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
For more information, visit Allergan's website at www.Allergan.com.
Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 (certain of such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
References:
1 RHOFADEtm Prescribing Information, 2017
2 National Rosacea Society, https://www.rosacea.org/rr/2010/winter/article_1.php, Last accessed on January 18, 2017
3 National Rosacea Society, https://www.rosacea.org/patients/allaboutrosacea.php, Last accessed on January 18, 2017
4 National Rosacea Society, https://www.rosacea.org/rr/2002/summer/article_3.php, Last accessed on January 18, 2017
5 National Rosacea Society, https://www.rosacea.org/weblog/risks_answer_why_me, Last accessed on January 18, 2017
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SOURCE Allergan plc
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