Optimus Pharma Gets Marketing Approval for Tapinarof Cream in Psoriasis
Mumbai: Optimus Pharma, a subsidiary of Sekhmet Pharmaventures, has secured marketing approval for tapinarof cream, a non-steroidal topical treatment indicated for plaque psoriasis.
The approval is supported by findings from a local clinical study involving 213 patients. In the study, tapinarof cream demonstrated statistically significant superiority over placebo in achieving Physician Global Assessment (PGA) success after 12 weeks of treatment.
The clinical study also showed numerical improvements in several secondary endpoints. These included Body Surface Area (BSA) involvement, the Peak Pruritus Numeric Rating Scale (PP-NRS), which evaluates the severity of itching, and Psoriasis Symptom Diary (PSD) scores.
The marketing approval was granted in the week preceding the publication of the report. As part of the approval requirements, Optimus Pharma has been directed to conduct a post-marketing safety study within three months. The additional study will provide further safety information following the product’s approval.
Optimus Pharma has secured approval for both the finished drug product and the bulk drug. According to the company, both will be manufactured at its in-house cGMP-compliant facilities, supporting the company’s integrated manufacturing capabilities.
Tapinarof is a prescription medicine used for the treatment of inflammatory skin conditions, including plaque psoriasis and atopic dermatitis (eczema). In the United States, the drug is marketed under the brand name Vtama by Organon, which was recently acquired by Sun Pharma.
Commenting on the regulatory milestone, Sumit Kumar, Chief Commercial Officer of Sekhmet Pharmaventures, stated that the approval of tapinarof represents a significant milestone for Sekhmet. He added that the development reflects the company’s commitment to bringing differentiated pharmaceutical products to patients while maintaining the highest standards of quality.
The approval therefore adds a non-steroidal topical treatment to Optimus Pharma’s dermatology portfolio and provides another therapeutic option for patients with plaque psoriasis. With approval covering both the finished formulation and bulk drug, and manufacturing planned at the company’s own cGMP-compliant facilities, Optimus Pharma is positioned to proceed with the next stages of product availability in accordance with regulatory requirements.
ETPharma reports that the approval was granted to Optimus Pharma following the clinical evidence demonstrating tapinarof cream’s efficacy against placebo, while the regulatory approval also includes the requirement for a post-marketing safety study within three months.
