Friday, 4 November 2011

Laquinimod News

After the phase 3 results (Allegro and Bravo studies) Teva's CEO Shlomo Yanai made the following statement concerning laquinimod: 


“Teva has held a meeting with the Food and Drug Administration (FDA) to discuss a new drug application (NDA) for laquinimod. Following the meeting we believe that it would be premature to file the NDA at this time. We will continue to study laquinimod, and the FDA has offered to work with us to determine the best design for conducting an additional trial to further explore the profile of this compound. We continue to believe that based on the data from our Phase III clinical development program, oral once-daily laquinimod is an important treatment option that reduces disability progression and brain volume loss, two of the most important goals in the treatment of patients with relapsing forms of multiple sclerosis.”  Shlomo Yanai, Teva's CEO.  

Source: Bioportfolio


"It is clear from these results and the CEO's statement that Teva will need to do more clinical trials to get laquinimod licensed." 

"I am of the opinion that Teva should have tested a large dose of laquinimod in the phase 3 program; hindsight is easy. A very expensive mistake? Hopefully, Teva will now pursue the program with a larger dose or possibly as an add-on to other drugs in separate studies."

CoI: Multiple

2 comments:

  1. Really like the 5 minute vegetable talk - I only realised the significance of Dr D' shirt after a few minutes :-)

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  2. And I needed this last hint and google images. Watched the whole video thinking it's just a pretty herbal print.

    ReplyDelete

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