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Who is the Manufacturer of Orgovyx?

2 min read

Approved by the FDA in December 2020, Orgovyx (relugolix) marked a significant milestone as the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist for advanced prostate cancer. The initial manufacturer and commercializing partner for Orgovyx was Myovant Sciences, Inc., working in collaboration with Pfizer, Inc.

Quick Summary

The manufacturer of Orgovyx (relugolix) is Myovant Sciences, which partnered with Pfizer for its commercialization. Myovant is now a subsidiary of Sumitovant Biopharma, maintaining its role in the drug's production. This partnership ensures the drug's availability and distribution for advanced prostate cancer treatment.

Key Points

  • Initial Manufacturer and Commercialization: Orgovyx was developed by Myovant Sciences, Inc., with commercialization supported by a partnership with Pfizer, Inc.

  • Parent Company Acquisition: Myovant Sciences was acquired by Sumitovant Biopharma in March 2023, making Myovant a subsidiary of Sumitomo Pharma Co., Ltd.

  • Active Ingredient: The active ingredient in Orgovyx is relugolix, which works by blocking GnRH receptors in the pituitary gland to reduce testosterone production.

  • Mechanism of Action: Orgovyx is a gonadotropin-releasing hormone (GnRH) receptor antagonist that directly and quickly lowers testosterone levels, unlike GnRH agonists that cause an initial hormone flare.

  • Route of Administration: As an oral tablet, Orgovyx offers a convenient alternative to traditional injectable androgen deprivation therapies (ADT).

  • Clinical Efficacy: Clinical trials demonstrated that Orgovyx achieved and maintained testosterone suppression more effectively than leuprolide injections.

  • Safety Profile: The HERO trial showed that Orgovyx was associated with a lower risk of major cardiovascular events compared to leuprolide.

In This Article

The Founding Partnership: Myovant Sciences and Pfizer

Myovant Sciences, Inc., a biopharmaceutical company specializing in men's and women's health treatments, is the initial manufacturer of Orgovyx. To enhance the commercial reach of Orgovyx, Myovant established a strategic collaboration with Pfizer, Inc., utilizing Pfizer's extensive global commercial infrastructure and expertise in distribution. This partnership was vital for the successful introduction of this novel oral therapy to the market.

Myovant's Evolution and Acquisition

In March 2023, Myovant Sciences was acquired by Sumitovant Biopharma, a subsidiary of Sumitomo Pharma Co., Ltd. This acquisition integrated Myovant into a larger, global organization. However, Myovant continues to play a key role in the production and commercialization of its products, including Orgovyx, through its ongoing partnerships.

How Orgovyx Functions: The Role of Relugolix

Relugolix, the active ingredient in Orgovyx, is a nonpeptide gonadotropin-releasing hormone (GnRH) receptor antagonist. This mechanism is crucial for its therapeutic effect in advanced prostate cancer, which is often dependent on testosterone for growth.

A Different Approach to Hormone Suppression

Orgovyx rapidly suppresses testosterone production without causing the initial surge, or flare, sometimes seen with traditional androgen deprivation therapies (ADT). Relugolix works by competitively binding to GnRH receptors in the pituitary gland, which reduces the release of LH and FSH, leading to a significant decrease in testosterone production. Lowered testosterone levels help inhibit the growth of most prostate cancer cells. The oral administration of Orgovyx provides a convenient alternative to injectable ADT, potentially improving patient adherence and quality of life.

A Comparison: Orgovyx vs. Lupron

Leuprolide (Lupron) has been a standard ADT for advanced prostate cancer. However, Orgovyx presents a distinct option with key differences.

Feature Orgovyx (relugolix) Lupron (leuprolide)
Mechanism of Action GnRH Receptor Antagonist GnRH Receptor Agonist
Route of Administration Oral tablet, once daily Subcutaneous or intramuscular injection
Testosterone Flare No initial testosterone flare May cause a temporary testosterone flare at initiation
Time to Suppression Rapid suppression of testosterone levels Delayed suppression, often preceded by a flare
Cardiovascular Risk Clinical trials showed a reduced risk of major cardiovascular events Historically associated with an increased risk of cardiovascular events
Patient Convenience Eliminates need for regular injections Requires clinic visits for injections

Advantages of the Oral Formulation

The oral formulation of Orgovyx offers significant convenience, removing the need for frequent clinic visits for injections and potentially enhancing treatment adherence. The rapid testosterone suppression without an initial flare also helps avoid a temporary worsening of symptoms associated with GnRH agonists.

Conclusion

The initial manufacturer of Orgovyx was Myovant Sciences, Inc., which partnered with Pfizer, Inc. for commercialization. Following its acquisition by Sumitovant Biopharma, Myovant remains integral to the drug's production and commercialization alongside Pfizer. Orgovyx, an oral GnRH antagonist, offers a convenient and effective treatment for advanced prostate cancer by providing rapid testosterone suppression without the initial flare seen with older injectable therapies.

Frequently Asked Questions

Orgovyx (relugolix) is used for the treatment of adult men with advanced prostate cancer. It is an oral medication that works by lowering testosterone levels in the body.

Myovant Sciences, Inc. developed Orgovyx, and then entered a commercialization partnership with Pfizer, Inc. Pfizer helps market and distribute the drug, leveraging its global resources.

Orgovyx is an oral GnRH antagonist, providing a convenient pill form of treatment. Unlike older injectable GnRH agonists like leuprolide, it does not cause a temporary surge in testosterone levels, known as a flare.

The Phase 3 HERO clinical trial demonstrated that Orgovyx was more effective at suppressing testosterone to castration levels than leuprolide injections. It also showed a reduced risk of major cardiovascular events.

Yes, following the acquisition by Sumitovant Biopharma, Myovant continues to be the key entity involved in the production and commercialization of Orgovyx, working within the larger Sumitomo Pharma organization.

Common side effects of Orgovyx include hot flushes, increased blood sugar and triglyceride levels, musculoskeletal pain, fatigue, constipation, and diarrhea.

Orgovyx received its U.S. Food and Drug Administration (FDA) approval for the treatment of advanced prostate cancer on December 18, 2020.

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.