Federal Circuit Rules Against Teva's Orange Book Patent Listings for ProAir HFA Inhaler
• The U.S. District Court ordered Teva Pharmaceuticals to remove its ProAir HFA inhaler device patents from the FDA's Orange Book, ruling they don't meet statutory listing requirements.
• The Federal Circuit affirmed that patents must claim the drug's active ingredient to be Orange Book listable, rejecting Teva's argument that device component patents qualify.
• The case, sparked by Amneal Pharmaceuticals' generic challenge, has drawn attention from major pharma companies and the FTC, potentially impacting future drug-device patent listings.
Pharma Field Forces Embrace Customer-Centric Approach in Digital Transformation Era
• Pharmaceutical companies are shifting from product-centric to customer-centric engagement models, driven by changing HCP preferences and accelerated digital transformation following COVID-19.
• Industry experts from Takeda, Novo Nordisk, and Sanofi emphasize the need for data-driven segmentation, personalized omni-channel strategies, and new metrics to measure quality of HCP interactions.
• Companies that take a holistic approach to sales operations transformation, rather than implementing isolated changes, are more likely to succeed in justifying field force value and improving customer engagement.
FDA Approves First Rapid-Acting Insulin Biosimilar Merilog for Diabetes Management
• The FDA has granted approval to insulin-aspart-szjj (Merilog), marking the first rapid-acting insulin biosimilar for diabetes treatment, expanding treatment options for over 38 million Americans with diabetes.
• Developed by Sanofi-Aventis as a biosimilar to Novo Nordisk's Novolog, Merilog is indicated for glycemic control in both adult and pediatric diabetes patients, available in pre-filled pens and multiple-dose vials.
• The approval represents FDA's ongoing commitment to increase access to affordable insulin options, joining two previously approved long-acting insulin biosimilars from 2021.
Isatuximab-irfc (Sarclisa) Approved for Multiple Myeloma Treatment
The U.S. Food and Drug Administration has approved Isatuximab-irfc (Sarclisa) for the treatment of multiple myeloma in specific settings, including in combination with other therapies for patients who have undergone prior treatments. The drug, a CD38-directed cytolytic antibody, has shown significant progression-free survival benefits in clinical trials.
Rilzabrutinib Shows Promise in Phase 3 Trial for Immune Thrombocytopenia
• Rilzabrutinib demonstrated a durable platelet response in 23% of ITP patients, compared to 0% with placebo, meeting the primary endpoint of the LUNA 3 trial.
• Patients receiving rilzabrutinib were approximately three times more likely to achieve a platelet response than those on placebo.
• The trial also met key secondary endpoints, including reduced bleeding, decreased need for rescue therapy, and improved physical fatigue and quality of life.
• Rilzabrutinib is currently under regulatory review in the US and the EU, with a target FDA action date of August 29, 2025.
Perioperative Nivolumab Demonstrates Sustained Benefits in Resectable NSCLC
• Patients with resectable non-small cell lung cancer (NSCLC) treated with perioperative nivolumab showed continued survival benefits, reinforcing its role in treatment strategies.
• Updated findings from a clinical trial reveal that nivolumab significantly improves event-free survival (EFS) and overall survival (OS) compared to chemotherapy alone.
• The study supports the integration of nivolumab into neoadjuvant and adjuvant settings for NSCLC, potentially altering the standard of care for these patients.
MRD Negativity Emerges as Key Endpoint in Multiple Myeloma Trials
• Minimal Residual Disease (MRD) testing offers a sensitive method for detecting remaining cancer cells, influencing treatment decisions and improving patient outcomes in multiple myeloma.
• The FDA's ODAC is considering MRD as a surrogate endpoint for drug approval, signaling a shift towards MRD negativity as a primary goal in clinical trials.
• Studies like CEPHEUS, with MRD negativity as the primary endpoint, highlight the increasing importance of achieving and sustaining MRD negativity for better progression-free survival.
• Sustained MRD negativity, particularly for 12 months or longer, significantly reduces the risk of disease progression or death in newly diagnosed multiple myeloma patients.
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