Tag Archives: Tradjenta

Trulicity on Medicare Negotiation List; Novo Outspends Lilly on GLP-1RA Advertising; Ro’s GLP-1RA Super Bowl Commercial

Three cardiometabolic-related news items have been observed: CMS included Lilly’s Trulicity for the third round of Medicare price negotiations (view press release); Novo spent nearly $500M on US advertising of Wegovy and Ozempic (view article); and Ro announced plans to air a “Healthier on Ro” Super Bowl commercial (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Mylan/Aurobindo Invalidates Two Tradjenta Patents; PRV-031 (Teplizumab) Ph3 PROTECT Trial Paused

According to new court documents (view here) released yesterday, two Boehringer patents on Tradjenta were ruled invalid by the U.S. Court of Appeals for the Federal Circuit upon reviewing the appeal by Mylan and Aurobindo. Additionally, Provention Bio announced a temporary pause in the patient randomization of the Ph3 PROTECT trial for PRV-031 (teplizumab) in patients with newly diagnosed T1DM amid the COVID-19 crisis (press release). Of note, the company is on track to complete its rolling BLA submission for teplizumab treatment of at-risk patients for T1DM in Q4 ’20. Below are the key highlights and insights from these new items.

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Trijardy XR (empa/lina/met XR FDC) Approved; Trijardy Label and Market Analysis

Late yesterday, Boehringer Ingelheim and Lilly announced FDA approval for their empagliflozin+linagliptin+metformin XR triple FDC, branded as “Trijardy XR.” Below, FENIX has conducted a Trijardy XR label analysis which includes a comparison to AstraZeneca’s Qternmet XR (dapa+saxa+met XR) as well as thoughts on the potential impact of the triple FDCs on the OAD market segment.

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