Two drugs being developed by
, one for a blood disorder and one for tumors in the digestive tract, will receive expedited review from the Food and Drug Administration.
The drugs, AMG 531 for immune thrombocytopenic purpura, and AMG 706, for mid-stage trials for gastrointestinal stromal tumors, received so-called "fast-track" review from the FDA, Amgen said Monday. The status allows Amgen to present its marketing application on a rolling basis and is generally conferred on drugs that treat diseases where existing medicine is deficient.
Immune thrombocytopenia purpura is an autoimmune bleeding disorder characterized by low levels of platelets in the blood that affects about 70,000 people in the U.S., the company said. Amgen's drug candidate is called a peptibody that is supposed to stimulate platelet production.
Amgen's candidate for gastrointestinal stromal tumors, which affect up to 10,000 Americans a year, is an oral treatment designed to inhibit various potentially cancerous growth factors and stop tumor growth. The drug is currently in phase 2 trials.
Amgen is up 59 cents, or 1%, to $63.85 in premarket trading Tuesday.