Product Approvals, Delays, & Disappointments

This was a busy week for Healthcare with 1Q22 Results and many data updates. The PharmaTell Team had eyes on some of the US FDA decisions + Roche’s data from their SKYSCRAPER-01 trial.

Approved! 

Lilly received an early FDA approval for Mounjaro (tirzepatide) for Type 2 Diabetes. The FDA press release (here) on the approval was positive with the following quote from Patrick Archdeacon, MD – Associate Director of the Division of Diabetes, Lipid Disorders, & Obesity in CDER:

Given the challenges many patients experience in achieving their target blood sugar goals, today’s approval of Mounjaro is an important advance in the treatment of type 2 diabetes”.

The FDA release and some research notes (here) also highlight the significant levels of weight-loss associated with the use of Mounjaro in patients in the study – a potential for additional indications for Mounjaro in the future.

Delayed

UCB announced last week that the FDA issued a CRL for Bimzelx for moderate to severe plaque psoriasis. Bimzelx is currently approved in several ex-US countries. Management stated that the CRL is based on manufacturing issues, not safety or efficacy, and feels that the issues are manageable but will delay approval. Analysts suggest the delay could be from 6 to 12 months and could impact not only ultimate commercial potential but also follow-on indications for the product. Analysts & Investors are looking for more clarity on the manufacturing issues. (see more here)

Disappointing Data

Roche announced that their Ph 3 SKYSCRAPER-01 trial did not meet the primary endpoint of progression-free survival (PFS) in NSCLC. The trial assessed tiragolumab + atezolizumab (Tencentriq) vs atezolizumab alone for patients with PD-L1-high locally advanced or metastatic NSCLC. In addition, the data for the co-primary endpoint of overall survival (OS) were immature so the study will continue until the next planned analysis. Roche is of course disappointed but is looking forward to the mature OS data to determine next steps. A summary of results can be found on CancerNetwork.com, and some analyst thoughts on implications for Roche and other TIGIT products in development can be found here and here.

Tip of the Week

The past few weeks have been full of data and model updates from the 1Q22 Results. We have been working to add transcripts from the earnings calls to the database as well. To find your companies of interest search the Company Catalogue and enter Transcript in the search box on the upper right to see the latest that have been included in the database.

If you haven’t activated your PharmaTell Studio account and can’t access the links or if you are interested in a free trial of PharmaTell, please send us an email to helpdesk@pharmatell.com and we will be happy to assist you.

What were you keeping your eyes on this week? Feel free to comment or drop us a note on the Pharma Intel you are tracking.  ‘Til next time – Robin

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