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March 31, 2009
A DPP-IV Compound Makes It Through
Posted by Derek
After talking the other week about the problems that Takeda has had with their DPP-IV inhibitor for diabetes, it now appears that AstraZeneca and Bristol-Myers Squibb have made it through the same narrows with their own drug. Saxagliptin has met the FDA's latest guidelines for cardiovascular safety, which (you'd think) will remove the biggest potential barrier to approval. The advisory committee is meeting today, so we'll see how their vote goes.
Comments (10)
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1. peej on March 31, 2009 11:57 AM writes...
Looks like Novo's compound -Liraglutide - might be in trouble though. Thyroid cancer and borderline CV data.
Saxagliptin looks good at this point, but who knows what the reviewers will say. Ad committee is actually Wednesday, with liraglutide meeting on Thursday.
Permalink to Comment2. Brian Orelli on March 31, 2009 7:59 PM writes...
I don't know. The FDA usually frowns on post-hoc analysis. (Ironic since that's how Avandia's heart problems were found). The advisory panel is actually tomorrow (4/1).
Permalink to Comment3. mike on March 31, 2009 10:41 PM writes...
did any of you guys nothe the similarity between galvus and the saxagliptin?Novartis needs some new patent guyz////
Permalink to Comment4. Damien on April 1, 2009 2:58 AM writes...
These new FDA rules have had a profound affect on the attractivness of diabetes as an indication for small spin out companies, its realy knocking the risk profile of the indication. I see the current drugs are continuing the pathway to development, but it will be interesting to see the effect it has on investors in the area, are big Pharma the only ones who are going to play in this field.
Damien Bove (www.damienbove.com)
Permalink to Comment5. MedChemMan on April 1, 2009 11:57 AM writes...
Though both saxagliptin and vildagliptin belong to the cyanopyrrolidine class of compounds, saxagliptin has shown better efficacy over vildagliptin (5 mg vs. 50 mg?) in the clinical trails. Hence, it is the dose that makes saxagliptin more safe and well-tolerated. However, I suspect that both saxagliptin and vildagliptin have only moderate-to-low selectivity against DASH enzymes, DPP8 & DPP9.
Permalink to Comment6. Anonymous BMS Researcher on April 1, 2009 9:12 PM writes...
Today, 1 April 2009, the FDA Advisory Committee voted 10 to 2 that the CV risk data for saxagliptan were sufficient to rule out unacceptable cardiovascular risk relative to comparators in the program.
Permalink to Comment7. Ex AstraZeneca Scientist on April 2, 2009 5:00 AM writes...
What slice of the pie will AZ take from this deal? 50:50?
Permalink to Comment8. Dr. Jo Jain on April 2, 2009 5:10 PM writes...
Both Novartis and Merck have DPP+Metformin Combos. What about Controlled Release Metformin+ Januvia/Galvus combos? My Endocrinologist says it would be helpful
Permalink to Comment9. Anonymous Former NVS Marketer on April 7, 2009 4:15 PM writes...
Galvus + Metformin = Eucreas. Only in EU. Beware of skin tox. Among others.
Permalink to Comment10. P.C.Shah on May 6, 2009 3:22 AM writes...
Janivia+Metformin available now in India too
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