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【drug-news】施贵宝-阿斯利康糖尿病新药Onglyza.获
* FDA requires future study of Onglyza's heart effects
* Drug will compete with Merck's Januvia (Adds FDA comments, competing drug)
WASHINGTON, July 31 (Reuters) - AstraZeneca PLC (AZN.L) and Bristol-Myers Squibb Co (BMY.N) won U.S. approval on Friday to sell a new diabetes drug called Onglyza.
The Food and Drug Administration said it was requiring a post-approval study to evaluate the drug's cardiovascular safety in higher-risk patients. Onglyza was not linked to increased heart problems in low-risk diabetics, the FDA said.
The drug's most common side effects include upper respiratory tract and urinary tract infections and headaches, the FDA said. Allergic-like reactions such as rashes and hives also were reported.
The companies hope Onglyza will carve out substantial sales by competing against Merck & Co's (MRK.N) blockbuster drug, Januvia, which sold $1.4 billion worldwide in 2008.
Both Onglyza and Januvia enhance the body's ability to lower elevated blood sugar levels and are part of a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors. (Reporting by Lisa Richwine; Editing by Phil Berlowitz, Leslie Gevirtz) 施贵宝-赛诺菲糖尿病新药Onglyza将给默克Januvia带来巨大竞争
New Diabetes Drug Could Give Januvia Stiff Competition
For a drug that is predicted to generate $1.7bn in sales and royalties by 2014 the diabetes drug Onglyza has slipped into the market with barely a ripple or movement in the share prices of partners AstraZeneca (AZN) and Bristol-Myers Squibb (BMY).
By late afternoon in London yesterday, Astra shares, which had risen 20% in the last three months, were flat at £27.91½. BMY shares were also stagnant in early New York trade at $21.80. This seeming lack of excitement by the market for the drug which is forecast to be the third and second biggest growth driver at each company respectively, is due to the fact that Friday’s thumbs up from the US regulator was widely expected and therefore largely in the shares prices of both groups.
The writing on the wall for approval started in April after an FDA advisory committee voted 10-2 to approve the drug, agreeing that the level of cardiovascular risk was acceptable when compared to other marketed products in the space (FDA panel review points to DPP-IV success in diabetes market, April 3, 2009).
Notwithstanding the hiccup of Onglyza’s PDUFA date being moved from the end of April to the end of July, (AstraZeneca and Bristol-Myers Squibb face short delay to Onglyza approval , April 23, 2009), additional confidence it would make to market was supplied by European regulators who, recommended approval for the drug on June 25.
Pre-approval jitters
However, despite these positive omens the ultra cautious in the market had predicted that the FDA might want to wait for the results of trials showing the drugs effects on the skin of patients with renal impairment before granting approval.
The worry about renal impairment goes back to pre-clinical studies that had shown Onglyza had the ability to cause skin lesions in monkeys, a similar side effect that prevented the US approval of Novartis’ (NVS) Galvus.
What appears to have prevented Astra and BMS from having to wait for the renal studies were the much higher doses of Onglyza that had to be used for lesions to appear, 60 times the maximum recommended dose, compared with just 6 to 8 times the maximum dose for Galvus.
Future competition
US approval of Onglyza leaves it as the second DPP-IV inhibitor on the market in the US, following the approval of Januvia in 2006, which managed to notch up impressive sales of $1.4bn last year.
DPP-IV inhibitors work by affecting the action of natural hormones in the body called incretins. Incretins decrease elevated blood sugar levels by increasing the body's utilisation of sugar, mainly through increasing insulin production in the pancreas and decreasing glucagon secretion.
Despite being second to market many are expecting that Onglyza will be able to capture a fair share. UBS believes that Onglyza’s smaller pill size and its once-daily combination with metformin, instead of twice-daily for Janumet, Merck & Co’s (MRK) sitagliptin and metformin combination pill, will help to drive sales. Astra also announced today that it would be pricing Onglyza at the same level as Januvia setting the two up for a battle for market share that could slow the impressive growth profile of Januvia, which is likely to retain its first mover advantage.
The approval of Onglyza should also give the handful of late-stage DPP-IV inhibitors queuing up to get a slice of the highly lucrative diabetes market some hope (see table). However, the most advanced, Takeda’s (TKPHF.PK) alogliptin, is staring down the barrel of a very long wait for approval following its failure to provide the FDA with enough clinical data to allow it to adequately assess the cardiovascular safety of the drug, which earned it a complete response letter in June (Alogliptin disappointment continues for Takeda, June 29, 2009).
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作者:admin@医学,生命科学 2010-11-23 17:11
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