Assuming All Drugs Under Clinical Trials Are FDA Approved, I

Assuming all drugs under clinical trials are FDA approved, I would like to know if the following drugs compete against each other. Indication is: Uterine leiomyoma 1. Assume Elagolix (Orilissa) is FDA approved for Uterine leiomyoma. In your view as a specialist, would a doctor consider it to be a substitute and a competitor to Ulipristal (Esmya) for purposes of treating patients? I note that the two drugs treat the same indication but have different mechanisms of action. 2. Why or why not? See below the research that we have already done (so it is not necessary to give me any background on the drugs): Approved Name (Alternate names) Ulipristal (Esmya, Ulipristal acetate, CDB-2914, VA-2914, Fibristal, RTI 3021-12, PGL-4001) Stage Launched (Uterine leiomyoma) Sales ($m) -- Indication Uterine leiomyoma, Pregnancy Mechanism of Action Selective progesterone receptor modulators Companies Involved Licensees: Allergan, Takeda, PregLem, Orient Europharma, Hyphens, XXXXXXX Richter Description Ulipristal is an antiprogestogen for oral use as an emergency post-coital contraceptive and for the treatment of uterine leiomyoma. It prevents progesterone from occupying its receptor, blocking usual gene transcription activity to prevent the formation of proteins to begin and maintain pregnancy. In Jan-19, Health Canada reported that ulipristal may be associated with serious liver injury. In Feb-18, European Medicines Agency said its PRAC is reviewing risks of ulipristal, following reports of serious liver injury, including liver failure. Launch, Geographic Details Uterine leiomyoma: In Feb-12, the EC approved ulipristal (Esmya) for treatment of of uterine leiomyoma. It was first launched in the UK in Apr-12 and has since launched in Austria, Czech Republic, Hungary, Poland, Portugal, France, Denmark, the Netherlands and Norway. In Aug-18, Allergan received a complete response letter (CRL) from the US FDA for ulipristal, citing safety concerns regarding Esmya and requesting additional information. In Oct-17, the US FDA accepted an NDA application for ulipristal for abnormal uterine bleeding in women with uterine fibroids. Endometriosis: Ulipristal was in Phase I development for endometriosis, and preclinical evaluation for breast cancer. There are no recent developments and active investigations seem to have ceased. Patent Details Ulipristal acetate is protected by a patent that expires in 2029. -------------------------------------------- Approved Name (Alternate names) Elagolix (Orilissa, NBI-56418, ABT-620) Stage Phase III (Uterine leiomyoma) Launched (Endometriosis) Sales ($m) $557m (‘20E) Indication Uterine leiomyoma, Endometriosis Mechanism of Action LHRH receptor antagonists Companies Involved Icahn School of Medicine at Mount Sinai (US): Originator AbbVie (US): Licensee Neurocrine Biosciences (): Licensee Description Elagolix manages pain associated with endometriosis and menorrhagia associated with uterine fibroids. It is a small molecule gonadotropin-releasing hormone receptor antagonist which inhibits endogenous GnRH signalling by binding competitively to GnRH receptors in the pituitary gland. Oral administration of elagolix causes a rapid, reversible, dose-dependent inhibition of luteinising hormone (LH) and follicle-stimulating hormone (FSH) secretion, which reduces the production of the ovarian sex hormones, estradiol and progesterone. Launch, Geographic Details Uterine fibroids, Uterine leiomyoma: Undergoing Phase III trials in UK and US. In Apr-19, AbbVie initiated a Phase III trial to assess safety and efficacy of elagolix in reducing heavy menstrual bleeding associated with uterine fibroids in premenopausal women. In Mar-18, it completed a Phase III study and met its primary efficacy endpoint to of elagolix in patients with uterine leiomyoma. An extension safety and efficacy study in Mar-19 was completed in treating uterine leiomyoma. Patent Details Neurocrine Biosciences has been granted six US patents for elagolix, some expiring in 2021 and some in 2024.