Health Canada Drug Approvals | Healthcare and Pharmaceutical News of Canada | News | Blogs | Canada
- ipharmaservices
- Sep 29, 2023
- 3 min read
September 27, 2023
Sun Pharma's Winlevi approved for acne
Sun Pharma has introduced a new topical treatment for acne called Winlevi, which contains clascoterone cream at a 1% concentration. The cream is approved for male and female acne patients aged 12 years and older and is now available in Canada.
Winlevi, which contains clascoterone, is significant because it is the first and only topical androgen receptor inhibitor approved by Health Canada for treating acne. It is the newest formulation in the last 40 years to target the hormonal component of acne.
Unlike other topical acne treatments that primarily address issues like follicular hyperkeratinization, inflammation reduction, or antibacterial effects, Winlevi works differently. It is believed to reduce the effects of acne-related hormones on the skin by disrupting the androgen cascade. While the exact mode of action is not established, Winlevi aims to inhibit the androgen receptors in the skin's sebaceous glands (oil-producing glands). Doing so helps reduce sebum (oil) production and inflammatory cytokines, which are associated with acne development.
In clinical studies, a 12-week course of Winlevi therapy demonstrated significant reductions in both inflammatory and non-inflammatory acne lesions. It also led to a substantial increase in patients achieving successful treatment outcomes compared to a vehicle (placebo) group.
In Phase 3 clinical studies, approximately 18.8% and 20.9% of patients treated with Winlevi achieved success, as assessed by their Investigator's Global Assessment (IGA) scores at Week 12, compared to 8.7% and 6.6% of patients receiving the vehicle (placebo) treatment. There were also significant reductions in both non-inflammatory lesion counts (NILCs) and inflammatory lesion counts (ILCs) among WINLEVI-treated patients compared to those receiving the vehicle.
Notably, adverse events related to Winlevi were rare, with no adverse drug reactions reported in more than 1% of patients. Most local skin reactions (LSRs) observed were of mild severity and occurred at similar rates in both the Winlevi and vehicle groups. Commonly reported LSRs included erythema (redness) and scaling/dryness.
Health Canada approved Rybrevant for EGFR exon insertion mutation NSCLC.
Janssen announced that Health Canada issued a Notice of Compliance with Conditions (NOC/c) to approve Rybrevant (amivantamab) for treating patients with EGFR exon 20 insertion mutation non-small cell lung cancer disease has progressed after platinum-based chemotherapy.
NOC/c was issued based on the CHRYSALIS study, in which the efficacy was demonstrated in patients whose cancer progressed after platinum-based chemotherapy. The efficacy was observed based on the overall response rate (ORR) and duration of response (DOR).
Janssen announced that Rybrevant targets both cancer-driving and resistant mechanisms. The drug previously received approval from the US FDA in May 2021.
Johnson and Johnson has announced that it has received the approval of Cabenuva
The Janssen Pharmaceutical Companies of Johnson and Johnson has announced that it has received the approval of Cabenuva (cabotegravir and rilpivirine extended release injectable suspensions) by Health Canada. Cabenuva is the first and only once-monthly, long-acting regimen for the treatment of HIV-1 infection in adults.
Cabenuva has two injections, one is Janssen's rilpivirine and the other is ViiV Healthcare's cabotegravir.
"At Johnson & Johnson, we are dedicated to changing the course of the HIV epidemic through our pursuit of improved therapies and the development of an HIV vaccine," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson.
The approval is based on ATLAS and FLAIR studies.
ATLAS study was a Phase 3, open-label active controlled study. The study designed to prove the non-inferiority of Cabenuva compared to two nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (INSTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or protease inhibitor (PI).
FLAIR is a Phase 3, open-label, active controlled study. The study included adult patients with HIV who are virologically suppressed (patients who were inducted with induction therapy with either dolutegravir/abacavir/lamivudine or dolutegravir plus 2 other NRTIs).
The company claimed that nine out of ten patients preferred Cabenuva compared to the oral daily treatment.
Trademark is owned by ViiV and Janssen. ViiV Healthcare holds the market authorization of Cabenuva in Canada. The drug is developed in collaboration between Janssen and ViiV.
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