US FDA approves J&J's psoriasis drug Stelara and Allos' cancer agent Folotyn

After lengthy deliberations, the US Food and Drug Administration has finally approved Johnson & Johnson subsidiary Centocor Ortho Biotech's Stelara (ustekinumab), a biologic product for adults who have a moderate to severe form of psoriasis, and Folotyn (pralatrexate), the first treatment for a form of cancer known as Peripheral T-cell Lymphoma (PTCL), an often aggressive type of non-Hodgkins lymphoma, manufactured by Allos Therapeutics.

Blockbuster potential perceived for Stelara

Stelara, which is seen to have a blockbuster potential because of its impressive effectiveness and infrequent administration, has been awaiting approval since late 2007.It enters an already competitive market, where Amgen's rheumatoid arthritis and psoriasis drug Enbrel (etanercept) had sales of $899 million in the second quarter and Abbott Laboratories' Humira (adalimumab) had sales of $1.3 billion in the same period.

Plaque psoriasis is an immune system disorder that results in the rapid overproduction of skin cells. About six million people in the USA have plaque psoriasis which is characterized by thickened patches of inflamed, red skin, often covered with silvery scales.

'This approval provides an alternative treatment for people with plaque psoriasis, which can cause significant physical discomfort from pain and itching and result in poor self-image for people who are self-conscious about their appearance,' said Julie Beitz, Director, Office of Drug Evaluation III, in the FDA's Center for Drug Evaluation and Research.

Stelara is a monoclonal antibody, a laboratory-produced molecule that mimics the body's own antibodies that are produced as part of the immune system. The biologic treats psoriasis by blocking the action of two proteins which contribute to the overproduction of skin cells and inflammation.

Three studies of 2,266 patients evaluated the biologic's safety and effectiveness. The FDA is requiring a risk evaluation and mitigation strategy or REMS for Stelara that includes a communication plan targeted to healthcare providers and a medication guide for patients.

Accelerated process for Folotyn

Folotyn was cleared under the FDA's accelerated approval process, which allows earlier clearance of drugs that meet unmet medical needs. It is approved for patients who have relapsed, or have not responded well to other forms of chemotherapy. 'Folotyn's approval demonstrates FDA's commitment to the rapid approval of drugs for rare and uncommon diseases,' said Richard Pazdur, Director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research.

The most common adverse reactions seen with Folotyn were irritation or sores of the mucous membranes such as the lips, the mouth, and the digestive tract, low platelet cell counts, low white blood cell counts, fever, nausea, and fatigue. Folotyn can harm a fetus. Women should avoid becoming pregnant while being treated with this drug and pregnant women should be informed of the potential risk. As a condition of accelerated approval, Allos will conduct studies to confirm that tumor shrinkage actually does predict that patients will live longer.