TEVA PHARMACEUTICALS USA, INC: Teva to Present New Fremanezumab Data, Including Long-Term Data, at the American Headache Society’s 60th Annual Scientific Meeting

Source: Teva Pharmaceuticals Usa, Inc

Teva Pharmaceuticals Usa Inc issued the following announcement on June 28.

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced 23 abstracts, one late-breaking poster and three oral presentations of fremanezumab for the preventive treatment of migraine which will be presented at the American Headache Society’s (AHS) 60th Annual Scientific Meeting in San Francisco from June 28-July 1, 2018. This is the first time that one-year analyses of fremanezumab are being presented. The new data include long-term response rates, acute headache medication use, and disability. Additional data presentations from clinical trials of fremanezumab examine efficacy, safety, quality-of-life impact, and reversion of patients from chronic to episodic migraine. Fremanezumab is an investigational therapy currently under review by the U.S. Food and Drug Administration (FDA) as a quarterly or monthly injection for the preventive treatment of migraine in adults.

“Migraine remains a challenging disease with considerable unmet need, due to availability of few therapeutic innovations over the past 25 years,” said Tushar Shah, M.D., Senior Vice President, Head of Global Specialty Clinical Development at Teva. “Teva is committed to developing novel treatments for patients with migraine headaches. We are excited to share additional data at the meeting on fremanezumab, particularly over the long-term, which is critical to patients.”

Antibodies targeting calcitonin gene-related peptides (anti-CGRPs), such as fremanezumab, are a new class of therapies developed for the prevention of migraine in adults.

Teva-sponsored abstracts at the AHS Annual Scientific Meeting include:

Late-Breaking Poster Presentation:

  • Response Over Time with Fremanezumab in the Treatment of Chronic and Episodic Migraine (Poster PF111)
    • Friday, June 29, poster Q&A, 1:15 - 2:15 pm PT

Platform Presentations:

  • The Impact of Fremanezumab on Medication Overuse in Patients with Chronic Migraine (IOR07)
    • Saturday, June 30, 8:00 am - 10:00 am PT
    • Presentation time: 9:00 am - 9:10 am PT
  • Response with Fremanezumab in the Treatment of Chronic Migraine (IOR11)
    • Saturday, June 30, 8:00 am - 10:00 am PT
    • Presentation time: 9:40 am - 9:50 am PT
  • Reversion of Patients with Chronic Migraine to an Episodic Migraine Classification with Fremanezumab Treatment (OR15)
    • Saturday, June 30, 2:15 pm - 3:45 pm PT
    • Presentation time: 2:15 pm - 2:25 pm PT

Long-Term Impact of Fremanezumab Posters (Yerba Buena Ballroom in the San Francisco Marriott Marquis):

  • Long-Term Impact of Fremanezumab on Response Rates, Acute Headache Medication Use, and Disability in Patients with Chronic Migraine: Interim Results of a One-Year Study (Poster PF14)
    • Friday, June 29, 1:15 - 2:15 pm PT
  • Fremanezumab Long-Term Efficacy and Safety: Interim Results of a One-Year Study (Poster PS30)
    • Saturday, June 30, 1:15 - 2:15 pm PT
  • Long-Term Impact of Fremanezumab on Response Rates, Acute Headache Medication Use, and Disability in Patients with Episodic Migraine: Interim Results of a One-Year Study (Poster PS35)
    • Saturday, June 30, 1:15 - 2:15 pm PT

Friday, June 29 Poster Sessions (Yerba Buena Ballroom in the San Francisco Marriott Marquis); presentations between 1:15 - 2:15 pm PT

  • Impact of Fremanezumab on the Number of Days with Use of Acute Headache Medications in Chronic Migraine (Poster PF08)
  • Efficacy of Fremanezumab in Patients with Chronic Migraine Who Had Prior Use of Topiramate or OnabotulinumtoxinA (Poster PF09)
  • The Impact of Fremanezumab on Headache-related Disability in Patients with Chronic Migraine Using the Headache Impact Test (HIT-6) (Poster PF12)
  • The Impact of Fremanezumab on Symptoms Associated with Migraine in Patients with Chronic Migraine (Poster PF15)
  • Onset of Action with Fremanezumab versus Placebo for the Preventive Treatment of Chronic Migraine (Poster PF19)
  • The Impact of Fremanezumab on Migraine-specific Health-related Quality of Life and Overall Health Status in Chronic Migraine (Poster PF23)
  • Efficacy of Fremanezumab on Migraine Frequency and Depression in Patients with Chronic Migraine and Comorbid Moderate to Moderately Severe Depression (Poster PF24)
  • The Impact of Fremanezumab on Work Productivity and Activity Impairment in Patients with Chronic Migraine (Poster PF33)
  • Onset of Action with Fremanezumab versus Placebo for the Preventive Treatment of Episodic Migraine (Poster PF43)
  • Impact of Fremanezumab on the Number of Days with Use of Acute Headache Medications in Episodic Migraine (Poster PF44)
  • Burden of Illness Among Treated Migraine Patients with ≥4 Headache Days in the past Month (Poster PF79)
  • The Impact of Fremanezumab on Headache-related Disability in Patients with Episodic Migraine Using the Migraine Disability Assessment (Poster PF82)
  • The Impact of Fremanezumab on Migraine-Specific Health-Related Quality of Life in Episodic Migraine (Poster PF87)

Saturday, June 30 Poster Sessions; (Yerba Buena Ballroom in the San Francisco Marriott Marquis); presentations between 1:00 - 2:15 pm PT

  • Relationship Between Fremanezumab Exposure and Efficacy in Preventive Therapy of Chronic Migraine in Adults (Poster PS31)
  • Relationship Between Fremanezumab Exposure and Efficacy in Preventive Therapy of Episodic Migraine in Adults (Poster PS32)
  • Efficacy of Fremanezumab in Patients with Episodic Migraine Who Had Prior Use of Topiramate or OnabotulinumtoxinA (Poster PS34)
  • Overview of Fremanezumab Pooled Safety Data from Placebo-Controlled Phase 2 and 3 Studies (Poster PS40)
  • Fremanezumab Cardiovascular Safety Profile: Pooled Data from Placebo-controlled and Long-term Studies (Poster PS41)
  • Lack of Relationship Between Fremanezumab Exposure and Cardiovascular Adverse Events in Phase 2 and 3 Data Including Chronic and Episodic Migraine Patients (Poster PS47)
  • The Impact of Fremanezumab on Symptoms Associated with Migraine in Patients with Episodic Migraine (Poster PS59)

Original source can be found here.

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Teva Pharmaceuticals USA, Inc. 1090 Horsham Rd. North Wales, PA 19454