Berlex will submit additional manufacturing data to FDA following a receipt of an "approvable" letter for Angeliq (drospirenone/estradiol).

FDA issued an approvable letter for the hormone therapy tablets requesting additional manufacturing information for the chemistry, manufacturing and control dossier, the company said Sept. 15.

The Schering AG subsidiary expects to submit the data in time for a final approval in 2005.

Berlex' original NDA, filed in February 2002, was deemed "not approvable" by FDA in October 2002.

The "not approvable" letter came three months after release of the NIH Women's Health Initiative results regarding Wyeth's Prempro (conjugated estrogens/medroxyprogesterone), which found increased risks of coronary heart disease, stroke and invasive breast cancer.

Berlex filed a response to the letter in late March 2004, starting a six-month review clock.

In announcing the approvable status, Berlex said it will pursue approval for Angeliq for only one dose: 0.5 mg drospirenone and 1 mg estradiol.

Since 0.5 mg is the lowest effective dose of drospirenone studied, the company has agreed to withdraw higher doses of drospirenone from the NDA, "pending completion of its studies investigating its potential blood pressure lowering effects."

In the post-WHI environment, FDA is advising that hormone therapy be given at of the lowest possible dose for the shortest time (¹ Also see "Berlex To Launch Menostar As Lowest Dose Estrogen Patch Approved For Osteoporosis Prevention" - Pink Sheet, 9 June, 2004.).

Angeliq is also in Phase III trials for an antihypertensive indication. The trials, which the company expects to last another year, have found a dose higher than 0.5 mg drospirenone is necessary for that indication.

- Andrew Shelton

Berlex' Angeliq Is "Approvable"; More Manufacturing Data Needed

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