Lev Pharmaceuticals submitted a "complete response" to FDA April 14, answering the agency's request for additional information on its BLA for Cinryze , a C1 esterase inhibitor for the acute and prophylactic treatment of hereditary angioedema.

In January, the company received a complete response letter from FDA requesting additional chemistry, manufacturing and controls information, plus additional analysis of efficacy data (¹ Also see "FDA “Approvable” For Lev’s Cinryze Opens Window For Jerini To Reach Market First" - Pink Sheet, 31 January, 2008.).

The New York-based firm said it expects to know within 14 days whether FDA considers the resubmission complete. At that time, the agency will designate the resubmission either Class 1, giving it a 60-day review, or Class 2, a 180-day review.

Lev is in a race to bring Cinryze to market for acute HAE, given the orphan nature of the indication. Of several drug makers with late-stage HAE treatments in their pipeline, however, Lev is the only one with prophylactic data.

The company will present the prophylactic data to FDA's Blood Products Advisory Committee May 2 (² Also see "Lev’s Cinryze To Get FDA Blood Products Advisory Committee Review" - Pink Sheet, 13 March, 2008.).

Agency action is anticipated shortly on German drug maker Jerini's application for the HAE treatment Firazyr (icatibant). The bradykinin blocker, a small molecule under review by a separate division at FDA, has an April 26 user fee date.

Potentially more threatening is CSL Behring's competing C1 esterase inhibitor, marketed in Europe as Berinert . The firm submitted its BLA to FDA for acute treatment of HAE in March (³ Also see "CSL Behring Submits C1-INH For Hereditary Angioedema" - Pink Sheet, 6 March, 2008.).

Timing is critical for these companies. Because the drugs have the same mechanism of action and are competing for an orphan indication, the second one to market could be blocked out of the acute treatment arena for seven years.

-Jessica Merrill (j.merrill@elsevier.com)

In First-to-market Race For HAE, Lev Submits Cinryze Complete Response To FDA

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