October 16, 2014 / 12:40 PM / 6 years ago

Novartis psoriasis drug benefits outweighs risk-FDA staff

(Reuters) - The benefits of Novartis AG’s anti-inflammation drug outweighed the risks in using it to treat a type of psoriasis, staff reviewers at the U.S. Food and Drug Administration said.

The injectable biologic, secukinumab, is part of an eagerly anticipated class of drugs called IL-17 inhibitors that have shown unprecedented success in plaque-psoriasis, the most common form of the painful skin condition.

A biologic is a protein-based drug cultured in a laboratory from living cells.

Secukinumab, or AIN457, is expected to be the forerunner in this kind of immunosuppressant therapy. This class of drugs targets the inflammation-causing protein interleukin-17 (IL-17), which plays a central role in psoriasis.

There were no major safety issues associated with secukinumab, according to the review posted on the FDA website on Thursday — four days before a panel of outside advisers is scheduled to meet.

The FDA is not obligated to accept the panel’s recommendations, but it typically does so.

Kepler Chevreux analysts expect Secukinumab, touted by Novartis as a potential blockbuster, to achieve peak sales of $701 million in 2020.

The Swiss company’s drug is dogged at the heels by rival IL-17 inhibitors under development.

Eli Lilly and Co said in August it would apply to market its ixekizumab in the first half of 2015.

Amgen Inc and partner AstraZeneca Plc reported in May favorable late-stage results for their anti-IL-17 drug, brodalumab.

Citigroup analysts expect sales in the psoriasis market to more than double to $7.6 billion by 2022 from $3.6 billion in 2012, helped by the new treatments.

The chronic autoimmune disorder, whose etiology is still unclear, affects about 125 million worldwide. It accelerates skin cell growth by up to ten-fold, manifesting as raised, red, scaly patches.

Another class of biologics, called tumor necrosis factor blockers — including Amgen’s blockbuster Enbrel and AbbVie Inc’s Humira — are widely used in psoriasis, but have potentially serious side effects.

More than half the patients receiving secukinumab experienced at least a 90 percent reduction in skin redness, thickness and scaling, compared with 21 percent of those on Enbrel, a late-stage study showed.

Secukinumab was also shown in more patients to have completely cleared skin, against those on Enbrel, based on a standard scale of psoriasis area and severity.

The FDA staff based the recommendation on the review of the data from this study, along with other trials.

Another study is evaluating secukinumab against Johnson & Johnson’s Stelara.

Eli Lilly’s ixekizumab also demonstrated significant improvement over Enbrel.

Novartis hopes secukinumab will also prove effective in other, larger inflammatory indications. Results of late-stage studies showed last month it improved symptoms of psoriatic arthritis.

Reporting by Natalie Grover and Samantha Kareen Nair in Bangalore and Caroline Copley in Zurich; Editing by Savio D'Souza and Joyjeet Das

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