Promius Pharma™ Receives FDA Approval for Sernivo (betamethasone dipropionate) Spray, 0.05%
HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)–Dr. Reddy’s announced today that its US subsidiary, Promius PharmaTM,
LLC, U.S. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), has received approval
for Sernivo™ (betamethasone dipropionate) Spray, 0.05% from the U.S.
Food and Drug Administration (FDA). Sernivo Spray, a prescription
topical steroid, is indicated for the treatment of mild to moderate
plaque psoriasis in patients 18 years of age or older. The commercial
launch of the product is planned for the coming quarter.
Commenting on the approval, G V Prasad, Co-Chairman and CEO, Dr. Reddy’s
Laboratories said, “The FDA approval of Sernivo Spray is a significant
milestone for Promius, as it validates our committed efforts and
resources to developing differentiated dermatology products from concept
to commercial launch. We are delighted to receive a first round FDA
approval of Sernivo Spray as we look to expand our portfolio of medical
dermatology products available in the US market.”
Promius has conducted two successful multi-center, randomized,
double-blind, vehicle-controlled clinical trials in subjects aged 18
years and older with moderate plaque psoriasis to evaluate the safety
and efficacy of Sernivo Spray. In both trials, randomized subjects
applied Sernivo Spray or vehicle spray to the affected areas twice daily
for 28 days. Enrolled subjects had body surface area of involvement
between 10% to 20%, and an Investigator Global Assessment (IGA) score of
3 (moderate). Efficacy was assessed as the proportion of subjects who
were considered a treatment success (defined as having an IGA score of 0
or 1 [clear or almost clear] and at least a 2-scale reduction from
baseline). Treatment success was achieved in significantly more subjects
using Sernivo than Vehicle at both Day 15 and Day 29 across both
studies. At Day 29 in Studies 1 and 2, Sernivo achieved treatment
success of 42.7% and 34.5% compared to vehicle success rates of 11.7%
and 13.6%, respectively (p<0.001).
Raghav Chari, Executive Vice President of Proprietary Products at Dr.
Reddy’s and President of Promius Pharma said, “As an emerging leader in
the dermatology space, we are committed to developing innovative
treatment options and support services for clinicians and patients. The
approval of Sernivo emphasizes our ongoing efforts and we look forward
to a successful launch of Sernivo Spray in the coming quarter.”
Important Safety Information
In controlled clinical studies, the most common adverse reactions (≥1%)
with 28 days of treatment with either Sernivo or placebo spray were:
application site reactions, including pruritus, burning and/or stinging,
pain, and atrophy. Do not use with occlusive dressings unless advised by
a physician. Treatment should be limited to 4 weeks. Avoid use on the
face, scalp, axilla, groin or other intertriginous areas or areas where
skin atrophy is present. Not for oral, ophthalmic or intravaginal use.
Warnings/Precautions: Betamethasone dipropionate can produce reversible
HPA axis suppression. Cushing’s syndrome, hyperglycemia and unmasking of
latent diabetes mellitus can result from systemic absorption of topical
corticosteroids. Pediatric patients may be more susceptible to systemic
toxicity when treated with topical corticosteroids and Sernivo is not
indicated for patients less than 18 years of age.
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is
an integrated pharmaceutical company, committed to providing affordable
and innovative medicines for healthier lives. Through its three
businesses – Pharmaceutical Services & Active Ingredients, Global
Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of
products and services including APIs, custom pharmaceutical services,
generics, biosimilars and differentiated formulations. Our major
therapeutic areas of focus are gastro-intestinal, cardiovascular,
diabetology, oncology, pain management and anti-infectives. Dr. Reddy’s
operates in markets across the globe. Our major markets include – USA,
Russia & CIS, Venezuela and India. For more information, log on to: www.drreddys.com
About Promius Pharma: Promius Pharma is a wholly owned subsidiary
of Dr. Reddy’s Laboratories, one of largest and most respected
pharmaceutical companies in the world. Our approach to product
development relies heavily on converting deep insights gained from
patients and physicians combined with strong collaborations with KOLs
throughout the development continuum into highly innovative product
concepts. Current R&D pipeline and commercialized products address the
needs of patients with dermatological and neurological conditions. The
company has successfully established a robust commercial infrastructure
and leverages the extensive research and development capabilities
available through its parent company. For more information, log on to www.promiuspharma.com.
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“plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”,
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herein.
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