The FDA declined the approval of Johnson & Johnson’s ne anti-inflammatory drug, Ustekinumab Psoriasis, because there is not information regarding the effects of the drug and the possible risks. The FDA didn’t ask for more tests that could take a while to be performed and the interpreted in ways that can be understood by people, but just more information on the drug itself.

It is very important that any medicine to come with a good description, that clearly explains both the benefits and the possible risks of the drug in cause. The company must also provide details on how it will assess the effectiveness of its communication strategies.

The new drug is an anti inflammatory, designed to work by inhibiting a type of protein called interleukin. According to specialists, the lack of drugs designed especially for the treatment of Psoriasis, a skin condition that affects approximately 17 million people in the US and Europe, will give Johnson & Johnson’s a possible profit of $500 million or more.

The new drug most be seen more clearly by regulators, as just a while ago, it was not known what the long term effects of the drug were and if the treatment would increase the chances of getting cancer.

There is definitely a need for this new drug, as just a couple of treatments for Psoriasis exist and a new treatment would be very well welcomed. On the other hand, without providing the necessary information related to the risks that the drug poses, it will never pass the FDA.