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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

« Another Obesity Drug? Not Likely. | Main | Mexican Lemons To the Rescue »

March 31, 2009

A DPP-IV Compound Makes It Through

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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) + TrackBacks (0) | Category: Diabetes and Obesity | Regulatory Affairs


COMMENTS

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 Comment

2. 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 Comment

3. 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 Comment

4. 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 Comment

5. 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 Comment

6. 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 Comment

7. 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 Comment

8. 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 Comment

9. 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 Comment

10. P.C.Shah on May 6, 2009 3:22 AM writes...

Janivia+Metformin available now in India too

Permalink to Comment

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