The U.S. Food and Drug Administration has approved Novartis’ (NVS) Ilaris (canakinumab) injection for the treatment of Active Still’s disease, including Adult-Onset Still’s Disease (AOSD).
AOSD is a rare and serious autoinflammatory disease of unknown origin. Autoinflammatory diseases are caused by abnormalities of the immune system, which trigger an inflammatory response that can damage the body’s own tissues. Characteristics of AOSD include fever, arthritis, rash and inflammation.
Ilaris was previously approved for Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.
“Prior to today’s approval, patients had no FDA-approved treatments for their disease, which can include symptoms such as painful arthritis, fevers and rash,” said Nikolay Nikolov, MD, of the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides patients with a treatment option.”
Common side effects reported by patients treated with Ilaris are infections (colds and upper respiratory tract infections), abdominal pain and injection-site reactions. The prescribing information for Ilaris includes a warning for potential increased risk of serious infections due to IL-1 blockade.
Ilaris was granted Priority Review designation, under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.
Shares in Novartis are currently trading down 8% year-to-date, and as a result Citigroup analyst Andrew Baum is taking an increasingly bullish view of the stock. He has just upgraded his NVS rating from Hold to Buy with a $109 price target (25% upside potential).
According to Baum, the stock is now trading at attractive levels and looks undervalued given its cardiovascular franchise potential post-Covid-19 and backlog of product launches in China. Overall the stock shows a Moderate Buy Street consensus. (See Novartis stock analysis on TipRanks)
Amarin, Apotex Settle Vascepa Dispute; Analyst Stays Sidelined
Jazz Pharma Scores Surprise Early Approval For Lung Cancer Treatment
Merck’s Gardasil Receives FDA Nod For Expanded Cancer Indications