Welcome to your Regulatory Index News update today, including a bio-similar approval for Pfizer, an FDA approval for an endometriosis treatment from AbbVie and a lupus treatment moving into Phase III.
Lilly to enter Olumiant into Phase III trials for lupus
Following Phase ll trials showing the benefit of Lilly’s JAK inhibitor Olumiant (baricitinib) in the treatment of global systemic lupus erythematosus (SLE), Lilly intend to progress into Phase III trials to evaluate its safety and efficacy. At week 24 a statistically significant proportion of patients treated with 4mg of Olumiant achieved resolution of their SLE-related arthritis or rash compared to placebo, which was the primary endpoint of the trial. A key secondary endpoint of a statistically significant greater proportion of patients with lower overall disease activity compared to placebo was also met. Please click here to read more on this from a PharmaTimes article.
Pfizer gains FDA approval for Neupogen biosimilar Nivestym
Although competing for the market share against Novartis' Neupogen (filgrastim) biosimilar Zarxio, Pfizer's Nivestym has been approved by the FDA and is anticipated to be marketed, according to Pfizer, at a "significant discount" to Amgen's reference drug. Pfizer's white blood cell stimulator will be available for all eligible indications of Amgen’s Neupogen, including decreasing the incidence of infection in some cancer patients. Please click here to read more on this from a PharmaTimes article.
AbbVie's new endometriosis drug Orlissa receives FDA Approval
This Tuesday saw the FDA approve AbbVie's gonadotropin-releasing hormone (GnRH) antagonist elagolix, the first oral treatment for moderate-to-severe endometriosis pain in over ten years. It is to be marketed under the name Orlissa and expected to go on sale in US pharmacies from August at a price of approximately $850 per month (just over $10,100 per year). It is the first of a number of new drugs on the market for the treatment of endometriosis pain, where previous treatment options were non-steroidal anti-inflammatories, hormone treatments or surgery. Please click here to read more on this from a BioPharmaDive article