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Exubera NDA Filed, But Inhaled Insulin Safety Issues May Complicate Review

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pfizer and Sanofi-Aventis submit Exubera NDA March 1; the first inhaled insulin to reach FDA could see approval by early 2006 based on a standard 10-month review. The companies expected to submit an NDA in 2001, but were delayed by pulmonary safety questions

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Licensing In Brief

Pfizer ups ante on Exubera approval with full license: Pfizer's decision to acquire Sanofi-Aventis' marketing rights to Exubera suggests the company is confident that the inhaled insulin product will receive FDA approval. Exubera's user fee date is Jan. 27, following a three-month extension resulting from an FDA request for additional technical chemistry data. Pfizer announced Jan. 12 that it will acquire worldwide rights for the development, production and commercialization of Exubera for $1.3 bil. - building on the firms' previous co-development alliance. The deal follows a judge's ruling that Sanofi's purchase of Aventis constituted a change-in-control under Pfizer and Aventis' 1998 agreement for Exubera. The NDA was submitted in March (1Pharmaceutical Approvals Monthly March 2005, p. 12)...

ADA Meeting In Brief

Pfizer/Sanofi-Aventis Exuberant over Phase III data: Pooled data from two Phase III studies involving 304 adults with type 2 diabetes showed that those taking Exubera inhaled insulin maintained glycemic control for two years and "experienced no clinically important effects on pulmonary function compared to patients treated with oral agents alone," Pfizer says. Data from a third study of 384 adults treated during a two-year open label extension further support the findings, the firm reports. Also presented at the American Diabetes Association meeting in San Diego June 10-14 was a fourth study with 226 patients showing that after three months, Exubera was "well tolerated and as effective as subcutaneous (injectable) short-acting insulin in achieving tight glycemic control in adults with type 1 diabetes." The most common adverse events were hypoglycemia and cough. Exubera has a Jan. 1, 2006 user fee date following a March NDA filing for type 1 and 2 diabetes; the filing was delayed by pulmonary safety concerns (1Pharmaceutical Approvals Monthly March 2005, p. 12)...

Diabetes Drug Advances Are Highlight Of NMEs Pending In 2005

Highlights of NME class of 2005 could be advances in diabetes, with Lilly/Amylin’s exenatide and Amylin’s Symlin currently being reviewed and Pfizer’s inhaled insulin Exubera slated for filing early in the year. Other major pending NMEs include J&J’s dapoxetine for premature ejaculation and Solvay’s irritable bowel syndrome agent Calmactin (cilansetron)

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