While the federal regulators have not asked for more clinical data, avoiding a hefty delay in its approval, the agency has requested the pharma giant to provide a strategically designed plan detailing potential risks of the drug.
"The Complete Response letter requests additional information, including a proposal ... for a risk evaluation and mitigation strategy to ensure the drug's benefits outweigh its risks," J&J said detailing the requirements of the letter.
As per the Complete Response letter, the company will now design a medication guide and a communication plan that would detail the risks and benefits of the medication, proper technique of administration and ways to minimize adverse outcomes. It would be circulated among patients and doctors.
Ustekinumab, a monoclonal antibody designed to work by inhibiting a type of protein called interleukin, is believed to play a role in psoriasis, an autoimmune skin disorder triggered by the overproduction of skin cells.
The disorder is typically characterized by the appearance of red scaly patches that may itch and bleed. The condition is often painful. The condition affects an estimated 7.5 million Americans and 10 million Europeans.
In the latest drug data touted by the company, the experimental psoriasis drug helped achieve significant skin clearance in two subcutaneous doses as against a series of 24 subcutaneous doses of Enbrel, the signature treatment jointly already marketed by Wyeth and Amgen.
Though the advisory panel had unanimously recommended Ustekinumab for approval, concerns about an increased risk of infection, reactivate tuberculosis and cancer
define still remained high.
However the company is confident that it can "expeditiously address the FDA's questions". Moreover, Jerome Boscia, senior vice president at Centocor, a unit of Johnson & Johnson that would market the drug, asserted, "We anticipate responding to the FDA in January 2009 and remain focused on bringing ustekinumab to market."
Post new comment