Bayer’s LYNKUET (elinzanetant) receives expanded authorization in Canada for breast cancer-related vasomotor symptoms
Bayer Canada announced that Health Canada has expanded the market authorization for LYNKUET (elinzanetant) to include the treatment of moderate-to-severe vasomotor symptoms (VMS) caused by adjuvant endocrine therapy (AET) related to breast cancer. The authorization makes LYNKUET the first approved treatment option in Canada for this patient population. The expanded indication is supported by results from the Phase III OASIS-4 trial, which evaluated elinzanetant in women receiving AET who experienced moderate-to-severe hot flashes and night sweats.
GSK’s Nucala (mepolizumab) receives positive CDA-AMC reimbursement recommendation for COPD
GSK Canada announced that Nucala (mepolizumab) has received a positive reimbursement recommendation with conditions from Canada’s Drug Agency (CDA-AMC) for use as an add-on maintenance treatment in adults with chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils and inadequately controlled by inhaled corticosteroid, long-acting beta2-agonist, and long-acting muscarinic antagonist therapy. The recommendation follows Health Canada’s approval of Nucala for this indication in June 2026 and represents a step toward potential public funding for eligible Canadian patients.
Roche Canada’s Perjeta (pertuzumab) completes pCPA negotiations for neoadjuvant treatment of early-stage breast cancer
Roche Canada announced that it has successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for Perjeta (pertuzumab) in combination with trastuzumab and chemotherapy as a neoadjuvant treatment for patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer who have tumors larger than 2 cm or node-positive disease. The agreement marks an important step toward public access, following a positive CDA-AMC recommendation issued in October 2025. Roche will now work with provincial and territorial jurisdictions to advance reimbursement decisions and expand access to this treatment across Canada.
Silo Pharma receives Notice of Allowance for Canadian patent covering SPC-15 for PTSD
Silo Pharma announced that the Canadian Intellectual Property Office (CIPO) has issued a Notice of Allowance for a patent application covering SPC-15, its intranasal 5-HT4 receptor agonist being developed for post-traumatic stress disorder (PTSD) and other stress-induced psychiatric disorders. The allowed application covers methods of preventing or delaying stress-induced fear and depressive-like behavior and enhancing stress resilience by administering selected 5-HT4 receptor agonists before a stressor. The milestone strengthens Canadian intellectual property protection for SPC-15 and follows corresponding patent protection granted or advancing in multiple international markets.
Arcutis’ ZORYVE (roflumilast) cream 0.05% approved in Canada for young children with atopic dermatitis
Arcutis announced that Health Canada has approved ZORYVE (roflumilast) cream 0.05% for the topical treatment of mild-to-moderate atopic dermatitis in children aged 2 to 5 years. The expanded approval extends the use of the non-steroidal phosphodiesterase-4 (PDE4) inhibitor to a younger pediatric population, providing an additional treatment option for children with atopic dermatitis. The authorization further expands the Canadian patient population eligible for ZORYVE and supports broader access to a non-steroidal topical therapy for managing this chronic inflammatory skin condition.
Knight Therapeutics launches WYNZORA (calcipotriol/betamethasone dipropionate) in Canada for psoriasis
Knight Therapeutics announced the launch of WYNZORA (calcipotriol 0.05 mg/g and betamethasone dipropionate 0.5 mg/g) in Canada for the topical treatment of psoriasis vulgaris in adults and adolescents aged 12 years and older. The fixed-dose combination cream, developed by MC2 Therapeutics, uses PAD Technology™ to provide an aqueous formulation designed to combine efficacy with ease of use. WYNZORA targets keratinocyte proliferation and differentiation while inhibiting pro-inflammatory cytokines including IL-23, IL-17A/F, and TNF-α, expanding treatment options for patients managing chronic psoriasis in Canada.
