FDA Approves Roche's Injectable Ocrevus, Novartis' Kisqali, and Lilly's Ebglyss; WHO Clears Bavarian Nordic’s Mpox Vaccine
Key Insights
Roche's Ocrevus gains FDA approval for an injectable version, offering a new administration option for multiple sclerosis (search) patients.
Novartis' Kisqali receives FDA approval to reduce the risk of recurrence in HR+/HER2- early breast cancer (search), expanding treatment options.
Lilly (search)'s Ebglyss (lebrikizumab-lbkz) is approved for moderate-to-severe atopic dermatitis (search) in adults and children 12 years and older.
The FDA has recently approved several new treatments, offering advancements in the management of multiple sclerosis (search), breast cancer (search), and atopic dermatitis (search). Simultaneously, the World Health Organization (WHO) has cleared a crucial vaccine for mpox (search), marking a significant step in global health efforts.
Roche's Ocrevus Receives Approval for Injectable Formulation
Roche's Ocrevus, a well-established therapy for multiple sclerosis (search), has now been approved by the FDA in an injectable form. This new formulation offers an alternative administration route for patients, potentially improving convenience and adherence. Ocrevus has demonstrated efficacy in reducing disease activity and slowing disability progression in relapsing and progressive forms of MS.
Novartis' Kisqali Approved to Reduce Breast Cancer Recurrence
Novartis has secured FDA approval for Kisqali to reduce the risk of recurrence in individuals with HR+/HER2- early breast cancer (search). This approval marks a significant advancement in adjuvant therapy, providing a new option for patients at risk of cancer recurrence. Kisqali, in combination with endocrine therapy, has shown a statistically significant improvement in disease-free survival, offering hope for improved long-term outcomes.
Lilly's Ebglyss (lebrikizumab-lbkz) Approved for Atopic Dermatitis
Lilly (search)'s Ebglyss (lebrikizumab-lbkz) has gained FDA approval for the treatment of moderate-to-severe atopic dermatitis (search) in adults and children 12 years and older. This approval provides a new biologic option for patients who have not responded adequately to topical therapies. Lebrikizumab, a monoclonal antibody targeting IL-13 (search), has demonstrated significant improvements in skin clearance and itch reduction in clinical trials.
WHO Approves Bavarian Nordic’s Mpox Vaccine
The World Health Organization (WHO) has cleared Bavarian Nordic’s mpox (search) vaccine, the first such shot to be approved by the agency for containing the spread of the disease in badly hit African countries. This approval is a critical step in controlling the mpox outbreak, particularly in regions where the disease is endemic. The vaccine has shown promising results in preventing mpox infection and reducing the severity of symptoms.
Other Industry Updates
In other industry news, MaxCyte announced a partnership with Kamau Therapeutics, while Revance Therapeutics reported that Crown Laboratories failed to initiate a tender offer by the deadline, impacting their acquisition agreement. Additionally, Cigna’s pharmacy benefit manager Express Scripts has sued the Federal Trade Commission, demanding a retraction of a recent report critical of drug spending negotiation practices. Nura Bio raised $68 million in funding, and Arzeda closed an oversubscribed $38 million funding round.