Reclast

Novartis med gets nod for fracture prevention

Tracy Staton — Thu, 05 Jun 2008 21:08:05 -0400

SPOTLIGHT: Novartis med gets nod for fracture prevention
Novartis said the FDA approved its bone-building drug Reclast as a treatment to prevent additional fractures following a hip fracture; the once-yearly drug's revised label includes data showing a 35 percent reduction in follow-up fractures. Report

FDA: Osteo meds can cause severe pain

Tue, 08 Jan 2008 06:59:58 -0500

Oh, the irony. The very drugs prescribed to strengthen bones can spark stabbing limb and joint pain, according to a reminder from the FDA. Info about the possibility of those pains--which can be incapacitating in some people--is included in the labeling for the bisphosphonate drugs, sold under the brand names Fosamax (Merck); Actonel (Procter & Gamble); Boniva (Roche); and Zometa and Reclast (Novartis). But, fearing that the cautionary language goes overlooked, the agency wanted to highlight it. The FDA is reviewing the problems and expects to report back in six months.

It isn't the first whiff of trouble for these osteoporosis drugs. Fosamax users have sued Merck, alleging that the drug caused their jaw bones to decay, a condition known as osteonecrosis. And the FDA is investigating bisphosphonates to see whether they may cause atrial fibrillation, a heart rhythm disorder.

Still, bisphosphonates remain extremely popular, with some 10 million Americans taking them. The class leader, Fosamax, delivered $3.1 billion to Merck's top line in 2006. And when cheaper copycats of that drug reach market--a development expected later this year--even more patients may have access to them.

- see this info sheet from the FDA
- read the report
- check out the Asbury Park Press article for more

Related Articles:
Merck expects $1.8B hit on Fosamax. Report
Merck touts Fosamax data. Report
Roche to Dr. Reddy's: Back off Boniva. Report
Novartis drug cuts hip-fracture deaths. Report

Novartis gains Aclasta, loses Prexige

Fri, 05 Oct 2007 06:59:57 -0400

From the good news, bad news file: Novartis got the EU's approval to sell its new osteoporosis drug Aclasta, known in the U.S. as Reclast. Reclast got the FDA's nod six weeks ago, and analysts are saying the drug is likely to generate $1.2 billion in sales by 2011--which unfortunately happens to be the year when its active ingredient goes off patent.

Practically simultaneously to the E.U.'s blessing on Aclasta, Canadian regulators pulled the pain pill Prexige because of the same liver-damage fears that brought it down in Australia in August. Some experts called Health Canada's ban a "knee-jerk" reaction; others questioned the fact that Prexige was approved at all, considering that it's a Cox-2 inhibitor, a class of drugs known to cause serious side effects.

You'll recall that Novartis and its stock analysts had big hopes for Prexige, once predicting yearly sales of $1 billion or more. So far this year, it's only generated $52 million.

- here's the press release on Aclasta
- see the MarketWatch article about Aclasta
- read this report on Prexige

Related Articles:
FDA says Aclasta "approvable" for Paget's. Report
Novartis' Reclast gets FDA blessing. Report
Australia bans Novartis' Prexige. Report
Vasella doubtful of Prexige approval. Report

Novartis drug cuts hip-fracture deaths

Tue, 18 Sep 2007 06:59:55 -0400

Big kudos to the Novartis osteoporosis drug Reclast: A New England Journal of Medicine study showed that patients with broken hips were more likely to survive if they were given a yearly dose of the drug. Twenty-eight percent fewer patients died, and Reclast reduced subsequent fractures by 35 percent, too.

Every year, some 300,000 patients 65 and older break their hips and, according to Boston Globe-sponsored research, 29 percent of them die within 12 months. In an editorial accompanying the new NEJM study, an NIH official called the reduction in death and fractures "striking" and said the study proved the need for "pharmacologic intervention" after hip fractures.

Sponsored by Novartis and headed by a researcher who has applied for two Reclast-related patents, the study data was independently reviewed by statisticians at the University of California.

- check out this press releaseﾠfrom Novartis
- read thisﾠarticle from the Boston Globe

Related Articles:
Novartis' Reclast gets FDA blessing. Report
Novartis options osteoporosis drug. Report
Cash-rich Novartis CEO mulls biotech buyouts. Report
Novartis touts pipeline. Report