Amgen preps an FDA pitch for its late-stage kidney drug

Amgen R&D Chief Sean Harper

After posting a trio of Phase III victories, Amgen ($AMGN) is plotting to submit the kidney dialysis drug AMG 416 for FDA review this year, charging forward with a successor to its own Sensipar.

The drug is designed to relieve symptoms of secondary hyperparathyroidism (SHPT), a disorder that affects patients with chronic kidney disease receiving hemodialyis. SHPT arises when the body attempts to adapt to declining kidney function by increasing production of parathyroid hormone to maintain healthy levels of calcium and phosphorus. Once dialysis kicks in, that excess parathyroid hormone becomes clinically dangerous, and AMG 416 is designed to intervene by interacting with the parathyroid gland.

And it did just that in a pair of Phase III trials presented at a medical meeting this week. Tested on a combined 1,023 patients, AMG 416 met its primary endpoints by significantly reducing parathyroid hormone levels, with 74.7% of subjects in the treatment arm reaching their targets compared to just 8.9% on placebo. In a third Phase III trial unveiled in February, the new drug also beat out Amgen's $1 billion-a-year Sensipar in controlling hormone levels.

Now Amgen is on track to file AMG 416 for global approvals this year, the company said, part of a make-or-break for the Big Biotech as it hustles a slew of late-stage assets toward the market.

The Thousand Oaks, CA, company entered 2015 with hopes of pulling off 5 drug approvals, and so far it's 1-for-2. In April, Amgen won an FDA nod for the long-delayed heart drug ivabradine, but the drugmaker was forced to scuttle hopes for the AstraZeneca ($AZN)-partnered anti-inflammatory treatment brodalumab last week in response to alarming rates of suicidal thoughts in the antibody's clinical data.

Amgen remains on track with evolocumab, an LDL cholesterol-lowering drug in a race with partners Sanofi ($SNY) and Regeneron ($REGN). The injection, to be marketed as Repatha, is up for an FDA decision by Aug. 27, about a month after the expected approval of Sanofi and Regeneron's alirocumab. Amgen is expecting a final decision on the cancer immunother talimogene laherparepvec by Oct. 27 and has filed an application to expand the indication for Kyprolis, the cancer treatment at the heart of the company's roughly $10 billion buyout of Onyx Pharmaceuticals.

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