Introduction to MYFEMBREE
MYFEMBREE, a fixed-dose combination tablet developed by Myovant Sciences and Pfizer, has recently received FDA approval for the management of moderate to severe endometriosis, in addition to its existing approval for heavy menstrual bleeding associated with uterine fibroids. The drug combines relugolix, estradiol, and norethindrone acetate, offering a once-daily administration that has shown promising efficacy and safety results in clinical trials.
Market Potential for MYFEMBREE
Endometriosis Market
The endometriosis market is projected to grow significantly, driven by the introduction of new treatments like MYFEMBREE. According to GlobalData, the endometriosis market is expected to grow from $1.05 billion in 2020 to $2.72 billion by 2030, at a compound annual growth rate (CAGR) of 10.0% across the seven major markets (US, 5EU, and Japan)[3].
MYFEMBREE is anticipated to be a key player in this growing market. GlobalData's Endometriosis Global Drug Forecast and Market Analysis to 2030 report suggests that MYFEMBREE could generate nearly $584 million in sales in the US alone by 2030[1].
Competitive Landscape
MYFEMBREE enters a market where other GnRH antagonists, such as AbbVie’s Orilissa (elagolix) and Neurocrine Biosciences’ Oriahnn, are already established. However, MYFEMBREE's once-daily administration and strong clinical trial results position it favorably.
- Orilissa (elagolix): Despite being the first to market, Orilissa has seen a slow uptake since its launch in 2018. MYFEMBREE's convenience and efficacy may attract patients and prescribers away from Orilissa[1][2].
- Oriahnn: Approved for both uterine fibroids and endometriosis, Oriahnn has a head start but faces competition from MYFEMBREE's simpler dosing regimen[2].
Clinical Efficacy and Safety
The Phase III SPIRIT 1 and SPIRIT 2 trials demonstrated significant pain reductions in women treated with MYFEMBREE. In the SPIRIT 1 trial, 74.5% of women with dysmenorrhoea and 58.5% with non-menstrual pelvic pain experienced clinically meaningful reductions, compared to 26.9% and 39.6%, respectively, in the placebo group[1].
These strong clinical outcomes are expected to drive adoption and market penetration.
Pricing and Revenue Projections
- Cost: A bottle of 28 MYFEMBREE tablets is priced at approximately $975 before rebates, according to an SEC filing[2].
- Revenue Projections: Myovant and Pfizer anticipate significant revenue from MYFEMBREE. For the first fiscal quarter of 2022, Myovant reported total revenue of $116.5 million, with MYFEMBREE being the top GnRH antagonist therapy for uterine fibroids, holding a 51% share of all prescriptions as of June 2022[4].
Given the market potential and the existing commercial success in uterine fibroids, MYFEMBREE is poised to generate substantial revenue in the endometriosis market as well.
Commercialization and Market Strategy
Myovant and Pfizer are well-positioned to leverage their existing commercial infrastructure and partnerships to drive the adoption of MYFEMBREE in the endometriosis market.
- Payer Coverage: The companies benefit from already established payer coverage for uterine fibroids, which is expected to facilitate quick approval for endometriosis treatment[4].
- Prescriber Base: MYFEMBREE already has a base of prescribers familiar with the medication, which will help in its rapid adoption for endometriosis[4].
- Overlap Between Conditions: There is a high overlap between uterine fibroids and endometriosis, allowing for a seamless transition in marketing and prescribing practices[4].
Regulatory Approval and Launch
After a brief delay due to FDA concerns, MYFEMBREE received approval for endometriosis in August 2022. The approval triggered a $100 million milestone payout for Pfizer and paved the way for a swift launch in the endometriosis market[4].
Key Takeaways
- Market Growth: The endometriosis market is expected to grow significantly, driven by new treatments like MYFEMBREE.
- Revenue Potential: MYFEMBREE is projected to generate nearly $584 million in US sales by 2030.
- Competitive Advantage: Once-daily administration and strong clinical trial results position MYFEMBREE favorably against existing treatments.
- Pricing: A bottle of 28 tablets costs approximately $975 before rebates.
- Commercial Strategy: Leveraging existing payer coverage and prescriber base will facilitate rapid adoption.
FAQs
Q: What is MYFEMBREE approved for?
A: MYFEMBREE is approved for the management of moderate to severe endometriosis and for heavy menstrual bleeding associated with uterine fibroids.
Q: What are the key components of MYFEMBREE?
A: MYFEMBREE is a fixed-dose combination tablet containing relugolix, estradiol, and norethindrone acetate.
Q: How does MYFEMBREE compare to other GnRH antagonists?
A: MYFEMBREE offers a once-daily administration, which is more convenient than the twice-daily regimen of some competitors like Orilissa.
Q: What is the projected market size for MYFEMBREE in the endometriosis market?
A: MYFEMBREE is anticipated to generate nearly $584 million in US sales by 2030.
Q: What are the key factors driving the adoption of MYFEMBREE?
A: Existing payer coverage, a base of familiar prescribers, and the high overlap between uterine fibroids and endometriosis are key drivers.
Sources
- Clinical Trials Arena: Myovant & Pfizer's MyFembree receives nod from the FDA for endometriosis[1]
- Fierce Pharma: Myovant and Pfizer's uterine fibroids med scores FDA nod, setting up showdown with AbbVie[2]
- Pharmaceutical Technology: Endometriosis market projected to grow at a CAGR of 10% between 2020 and 2030[3]
- Fierce Pharma: As Pfizer, Myovant's bid to expand Myfembree use draws near, execs say[4]
- Pfizer: Myovant Sciences and Pfizer Receive FDA Approval for MYFEMBREE®[5]
