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.
Psoriasis 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.
Approximately, 7.5 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.
- 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.
Facts about the Psoriasis Spray, Sernivo:
- Contains 0.05% betamethasone dipropionate
- Can be used by patients who are 18 years or older
- Should be used only for external application
- Useful in mild to moderate cases of psoriasis
- Should not be used for more than 28 days
Clinical Trials using Sernivo:
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.
According 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.”
Indian pharmaceutical 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 virus.