A US subsidiary of Dr
Reddy's laboratory, Promius Pharma, has been successful in getting US FDA
approval for its psoriasis spray. This prescription spray, called Sernivo,
contains 0.05% betamethasone dipropionate
and can be used for external application for psoriasis
among patients who are 18 years or over.
"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" said Raghav Chari, Executive Vice President of Proprietary
Products at Dr. Reddy's and President of Promius Pharma.
‘The Sernivo spray from Promius Pharma, a US subsidiary of Dr Reddy’s laboratory, offers new hopes for psoriasis patients.’
is a condition in which skin cells begin to multiply rapidly and form silvery scales on skin lesions that are dry, red and patchy. Sometimes, the entire area may be painful. Though medications are
available for its treatment, psoriasis in general is difficult to treat.
million Americans are affected by psoriasis.
Therefore, an effective treatment measure would help a considerable number of
people. Research has found that untreated and severe psoriasis can increase the risk of cardiovascular disease
Facts about the Psoriasis Spray, Sernivo:
- Betamethasone is a strong corticosteroid used to treat a variety of skin conditions.
- It should not be applied on the face, groin or the under arms
- It should be applied twice a day on
the affected site
- It can cause itching at the site of
application. Treatment should be stopped at this stage.
- Contains 0.05% betamethasone dipropionate
- Can be used by patients who are 18
years or older
- Should be used only for external
- Useful in mild to moderate cases of
- Should not be used for more than 28
The benefits of
Sernivo were established through two clinical trials. Patients with 10 to 20%
psoriasis were included in the study and were asked to either use Sernivo twice
a day or its inert vehicle for 28 days.
Results of the Study:
There was significant
improvement in psoriasis, in both the trial studies in patients who used
Sernivo as compared to those who used the vehicle.
On day 29 in the first
study, 42.7% patients were successfully treated after Sernivo while success
rate in patients using vehicles was 11.7%.
In study 2, the
success rate among patients using Sernivo was 34.5% while in patients using
vehicle it was 13.6%
The promising results
open the doorway for better treatment and care of psoriasis
patients. The US
FDA approval is a boost for the Indian pharmaceutical giant, promising to provide innovative solutions to patient care and treatment. The official sales launch will take place later this year.
to Mr G.V. Prasad, co-chairman and chief executive officer of Dr Reddy's "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."
companies are taking significant steps in the global pharmaceutical market.
Recently, Bharat Biotech was in the news for developing a vaccine that might be effective against the Zika