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Addyi (flibanserin): How an upstart biopharma used social media and policy tools to support its NDA approval - and a $1 billion payday

ID: PSM-368


Features:

49 Info Graphics

2 Data Graphics

57 Metrics

3 Narratives


Pages: 62


Published: 2020


Delivery Format: Shipped


 

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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • VIEW TOC AND LIST OF EXHIBITS
Developed in early 2000s for anxiety, flibanserin was repositioned for hyposexual desire disorder (HSDD) in the mid-2000s by Boehringer Ingelheim. Following the rejection of the first clinical submission by FDA in 2010, Sprout Pharmaceuticals acquired the development rights of flibanserin from Boehringer Ingelheim, only to face the drug's second rejection in 2013.

Rising from the ashes of two FDA rejections, Sprout Pharmaceuticals adjusted its clinical development plan and used active lobbying, policy and social media campaigns to chart a new market entry point. Gaining FDA approval in 2015, Addyi (flibanserin) became the first drug to be approved in the HSDD category.

This Best Practices, LLC case study examines how Sprout Pharmaceuticals employed lobbying and social media to convince regulators to reconsider previous objections to the drug and to ultimately win approval for the controversial therapy, Addyi.

Industries Profiled:
Pharmaceutical


Companies Profiled:
Boehringer Ingelheim; Sprout Pharmaceuticals; Valeant

Study Snapshot

Best Practices, LLC conducted extensive secondary research of government and company information to review how Sprout Pharma used social media, active lobbying and policy levers to win approval for its controversial therapy, Addyi® (flibanserin) in female hypoactive sexual desire disorder (HSDD) category.

Key Findings

Select key insights uncovered from this report are noted below. Detailed findings are available in the full report.

  • Build Policy on Science: Sprout used medical experts to bring credibility to HSDD and the policy issue regarding unequal treatment of women’s health before the FDA.
  • Using Social: Sprout used social media as a policy-shaping and influencing tool during the FDA evaluation phase of flibanserin's third submission.

Table of Contents

Sr. No.
Topic
Slide No.
I.
Introduction: From Rejections to Market EntryPg. 4
II.
Adjusting Clinical Development Plan: Path to ApprovalPg. 12
III.
Political Pivot: Developing Political Pressure for Drug ReviewPg. 20
IV.
Social Media: Flexible Tool to Inform, Educate and AdvocatePg. 29
V.
The Decision: Positive Review from FDAPg. 45
VI.
Ongoing Controversy: Debate on Efficacy, Risks and Clinical DataPg. 49
VII.
In-Market: Commercial Blues and Future of AddyiPg. 52
VIII.
Lessons Learned & Winning StrategiesPg. 57

    List of Charts & Exhibits

    I. Introduction: Rising from the ashes of two FDA rejections, flibanserin changes clinical and political tactics to find its market entry point

    • Addyi’s birth story
    • Market landscape
    • Flibanserin’s NDA approval timeline
    • Detailed timeline of Addyi’s long journey to approval
    • How Sprout Pharmaceuticals set out to succeed where others failed
    • Sprout’s brand team spotlight
    • Addyi’s focus on educating the world around HSDD

    II. Adjusting Its Clinical Development Plan: Addyi finetuned its focus, measurement and clinical endpoints to find its path to approval

    • Addyi’s method of action
    • FDA prioritization of HSDD disease area
    • FDA rejection of flibanserin for HSDD during the first submission for approval
    • Adverse events leading to flibanserin's FDA rejection during the second regulatory submission
    • Refining clinical plan to achieve FDA approval reflecting regulatory and clinical measurement hurdles
    • Comparative effectiveness of flibanserin against placebo
    • Adverse events comparison of flibanserin against placebo

    III. Political Pivot: Addyi employed lobbying and social media to apply political pressure to the New Drug Review process

    • Using lobbying tools to confront gender bias in women’s health NDAs
    • Getting constituents to raise their voices
    • Wining support for fair treatment of women’s health NDAs before the FDA
    • Garnering political support seeking “thoughtful consideration” of flibanserin’s NDA
    • Using Twitter platform for education and policy campaigns
    • Building policy on science
    • Demanding equity before FDA with “Even The Score” - an innovative political and health advocacy group
    • Linking tools to grab more attention

    IV. Social Media: Addyi used social media as a flexible tool to inform, educate, advocate and apply political pressure

    • Use of social media as a policy-shaping and influencing tool during the FDA evaluation phase of flibanserin's third submission
    • Use of social media to educate and inform around women’s health issues
    • Spotlighting unmet needs through social campaigns
    • Using social media to deploy disease state education
    • Spotlighting gender bias in treating women’s sexual dysfunction as seriously as male erectile dysfunction
    • Supporting bias charge with science and policy analysis
    • Campaign highlighting the importance of gender-based analysis
    • Giving voice to advocacy groups
    • Forging alliances to quickly expand the pool of support
    • Demonstrating evidence
    • Providing testimonials on social media platforms
    • Using Twitter campaign to bring the women’s health issue into public light and discussion
    • Spotlighting the impact of HSDD
    • Questioning status quo

    V. The Decision: FDA bends and provides a positive review

    • FDA approval of Addyi in 2015 amid positive data - but with a few conditions
    • Terms of the definitive $1 billion agreement between Valeant and Sprout
    • Development of a comprehensive risk evaluation and mitigation strategy (REMS) program

    VI. Ongoing Controversy: Debate continued post approval regarding efficacy, risks and data for this new product

    • Reasons to be sceptical of Addyi
    • HCP and patient commentaries

    VII. In-Market: Commercial Blues and Future of Addyi

    • Addyi’s market-entry
    • Addyi revenues following launch
    • Valeant’s own struggles
    • Valeant giving Addyi back to its founders shortly after the drug’s launch

    VIII. Lessons Learned & Winning Strategies
    • Lessons learned and winning strategies from Addyi