Monthly News Roundup - June 2020

Genentech’s Phesgo Approved Four Months Early for At-Home Breast Cancer Treatment

The U.S. Food and Drug Administration (FDA) has approved Phesgo, a new option for at-home breast cancer treatment. Phesgo is a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, for the treatment of early and metastatic HER2-positive breast cancer.

FDA Approves Fintepla for Childhood Seizures Associated with Dravet Syndrome

Dravet syndrome is a rare childhood epilepsy marked by frequent debilitating seizures, developmental impairments, and an increased risk of sudden death.

Gimoti Nasal Spray is Cleared for Diabetic Gastroparesis in Adults

This month, the FDA approved Evoke Pharma’s Gimoti (metoclopramide) nasal spray, a dopamine-2 (D2) antagonist and the first nasal spray for adults with acute and recurrent diabetic gastroparesis.

• In diabetic gastroparesis, delayed emptying of the stomach can cause nausea, stomach pain, bloating, early satiety (feeling full) as well as vomiting and can interfere with absorption of oral medications.
• The nasal spray formulation allows the drug to enter the bloodstream directly and may provide more predictable delivery. The recommended dosage is 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum of 4 sprays daily) for 2 to 8 weeks, depending on symptomatic response.
• The effectiveness of Gimoti was established based on studies of oral metoclopramide in diabetic gastroparesis. Gimoti contains a Boxed Warning for tardive dyskinesia and the most common side effects (≥5%) are: dysgeusia (altered taste), headache, and fatigue.

Zepzelca Receives Accelerated Approval for Metastatic Small Cell Lung Cancer

PharmaMar and Jazz Pharmaceuticals announce accelerated approval of Zepzelca (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression, after platinum-based chemotherapy. Zepzelca is an alkylating drug that interrupts the cell cycle causing cell death.

FDA Approves Lyumjev, a Lower-Cost Insulin for Type 1 and Type 2 Diabetes 

In June, the FDA cleared Eli Lilly’s Lyumjev (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), a rapid-acting insulin indicated to improve glycemic control in adults with type 1 diabetes and type 2 diabetes. Lyumjev controls high blood sugar levels after meals, similar to how natural insulin works in those without diabetes.

• In Phase 3 comparative studies of Lyumjev and Humalog (insulin lispro injection, 100 units/mL), Lyumjev demonstrated noninferior A1C reduction from baseline compared to Humalog at 26 weeks, when Lyumjev and Humalog were dosed at mealtime.
• Lyumjev and Humalog also had similar safety and tolerability profiles.
• Lyumjev will be included in the Lilly Insulin Value Program, allowing anyone with commercial insurance and those without insurance to fill their monthly prescription for $35. This savings option can be obtained by calling the Lilly Diabetes Solution Center at (833) 808-1234.

FDA Approves Uplizna for Neuromyelitis Optica Spectrum Disorder (NMOSD)

In June, the FDA approved Viela Bio’s Uplinza (inebilizumab-cdon), a CD19-directed cytolytic antibody, for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive.

 

 

 

 

Posted: June 2020