As per the preliminary review of the data provided by the U.S. Food and Drug Administration, Onglyza could be a death promoter. The diabetes pill manufactured by AstraZeneca plc (ADR) (NYSE:AZN), has been associated with an increased rate of death. The report was posted on the agency’s website on Friday.
Winning the U.S approval on 2009, Onglyza has a twin drug named Nesnia, which won the U.S approval in 2013. Nesnia is manufactured by Takeda Pharmaceutical Co. Ltd (TYO:4502) On April 14, the FDA shall organize a meeting of its advisory panel members to discuss the safety of both the drugs. More than 16,000 patients have shown that Onglyza causes increased risk of hospitalization because of heart failures. Onglyza is also known as saxagliptin.
However, Takeda’s Nesina drug, from the same class of drugs (called as the DPP-4 inhibitors) have not raised such concerns, as per FDA documentation. Those taking the placebo as well as Nesina have shown statistically similar rate of hospitalization for heart failure. This was evident from a study called EXAMINE.
The agency believes that the risks involved are valid. However, the overall trial results did not reveal a higher risk of death. According to the review, analyzing only those patients consuming the drig suggested a “significantly increased risk” of mortality caused by all kinds of risks. The FDA has also mentioned that many patients have had several serious medical conditions before their death. Also the causes of the deaths reported were often “multifactorial”.
That being said, the FDA also mentions in its report that they do not “necessarily view this pattern of variable causes” as the evidence to the mortality signal might be due to chance.
Seamus Fernandez, a Leerink analyst said that FDA’s concerns over the mortality were unexpected. This might lead to a slash of 50% sales of Onglyza, if Januvia does not show similar problems. Januvia is under examinations and the results are expected in June. It leads the market of DPP-4 inhibitor. It is manufactured by Merck & Co., Inc. (NYSE:MRK).