New FDA Approvals, Biosimilars Highlight SPT Week in Review

5. Investigational Drug Reduces Cluster Headache Attacks in Phase 3 Study

Eli Lilly’s investigational drug for the prevention of episodic cluster headache met its primary endpoint in a phase 3 study. Read more.

4. FDA OKs Truvada to Reduce HIV Risk in Adolescents

Gilead Sciences, Inc. announced that the FDA approved once-daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Truvada) in combination with safe sex practices, to reduce the risk of sexually acquired HIV-1 in at-risk adolescents. Read more.

3. Biosimilars: The Last 'Patent Dance'

In an unprecedented unanimous ruling on June 12, 2017, the Supreme Court ruled that biosimilar drug manufacturers applying for approval from the FDA “may provide notice of commercial marketing to the branded biologic drug manufacturer before obtaining a license.” Read more.

2. Novel Preventive Migraine Treatment Gains FDA Approval

Officials with the FDA have approved erenumab-aooe (Aimovig, Amgen) for the preventive treatment of migraine in adults, making it the first approved preventive migraine treatment of its kind. Read more.

1. FDA Approves Epoetin Alfa Biosimilar

The FDA granted approval to epoetin alfa-epbx (Retacrit) as a biosimilar—not an interchangeable drug—to epoetin alfa (Epogen/Procrit). Read more.