Celgene's Filing For Ozanimod Accepted For Review In US/EU
Zacks Investment Research | Jun 07, 2019 05:00AM ET
Celgene Corporation (NASDAQ:CELG) announced that the FDA has accepted for review the new drug application (NDA) for ozanimod for the treatment of people with relapsing forms of multiple sclerosis (RMS) in the United States. The European Medicines Agency (EMA) also accepted for review the Marketing Authorization Application for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) in the European Union.
The FDA has set an action date of Mar 25, 2020. A regulatory decision from the EMA is expected in the first half of 2020.
Shares of Celgene have surged 48.6% year to date compared with the industry ’s growth of 0.3%.
The FDA and EMA applications are based primarily on ozanimod data from the SUNBEAM and RADIANCE Part B phase III studies.
The SUNBEAM study evaluated the efficacy, safety and tolerability of two doses of oral ozanimod against weekly intramuscular interferon beta-1a (Avonex) for at least a 12-month treatment period. The primary endpoint of the trial was annualized relapse rates (ARR) during the treatment period in 1346 participants with RMS.
In February 2017, Celgene announced positive top-line data from the SUNBEAM study, which revealed that both ozanimod treatment arms demonstrated statistically significant and clinically meaningful improvements compared with Avonex for the primary endpoint of ARR. The top-line data that Celgene announced in May 2017 from the RADIANCE study also showed that the primary endpoint and key secondary MRI endpoints were met.
However, in February 2018, the company received a Refusal to File letter from the FDA regarding its NDA for ozanimod for the treatment of people with RMS. Upon its preliminary review, the FDA determined that the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a complete review. The company then submitted a NDA again in March 2019 to the FDA based on data from the SUNBEAM and RADIANCE studies.
MS is a crowded market, with many companies already having drugs in their portfolio approved for this indication. Biogen (NASDAQ:BIIB) holds a strong position in the MS market with a wide range of products, including Avonex, Tysabri, Tecfidera and Plegridy. Israel-based Teva Pharmceuticals (NYSE:TEVA) has long been in the MS market with its widely used drug, Copaxone, which is facing stiff generic competition for the past few years.
Get The News You Want
Novartis’ (NYSE:NVS) MS portfolio comprises approved drugs like Gilenya and Extavia for the treatment of RMS.
Zacks Rank
Celgene currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple (NASDAQ:AAPL) sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market. Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Zacks Investment Research
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.