FDA approves Incyte's eczema cream with boxed warnings
Reuters
Published Sep 21, 2021 05:38PM ET
Updated Sep 21, 2021 09:51PM ET
By Bhanvi Satija and Manojna Maddipatla
(Reuters) - The U.S. Food and Drug Administration on Tuesday approved Incyte (NASDAQ:INCY) Corp's cream Opzelura for treating inflammatory skin condition atopic dermatitis, commonly called eczema, in adolescents and adults with boxed warnings.
The label for Opzelura carries the health regulator's JAK-class warning, flagging risks of serious infections, increased risk of heart attack, stroke or cardiac death.
Shares in the company, which expects to make the cream available in U.S. pharmacies in the coming weeks, were down about 5% at $72.26 after the bell.
RBC analyst Brian Abraham said in a client note that boxed warnings could have a limiting impact on both the long-term opportunity and near-term stock reaction.
The brokerage's physician survey had indicated that a boxed warning on Opzelura's label could reduce adoption by about 30%, particularly in more mild patients, said Abraham in client note.
The ruxolitinib cream is the first topical JAK inhibitor, a class of treatments that work by blocking inflammation-causing enzymes Janus kinases, to be approved in the United States.
Recent safety concerns over oral JAK inhibitors such as Pfizer Inc (NYSE:PFE)'s arthritis drug Xeljanz and AbbVie Inc (NYSE:ABBV)'s treatment Rinvoq and Eli Lilly (NYSE:LLY)'s Olumiant, have led to regulatory delays.
Atopic dermatitis is a chronic skin condition that causes inflammation and irritation of skin. It affects about 30% of the U.S. population, mostly children and adolescents, according to the National Institute of Allergy and Infectious Diseases.
Ruxolitinib is approved as an oral tablet under the brand name Jakafi in the United States for the treatment of a type of blood cancer called polycythemia vera, rare bone marrow cancer myelofibrosis and acute Graft-Versus-Host Disease.
RBC's Brian estimates U.S. sales of more than $550 million out-year for the atopic dermatitis indication.
Get The News You Want
Written By: Reuters
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.