Vivus acquired $10.69 to $21.24 at 9:50 a.m., its better intraday access back 1999. The shares of NeuroSearch A/S and Novo Nordisk A/S, Danish companies developing blubber drugs, aswell acquired afterwards the Food and Biologic Administration admiral voted 20-2 bygone that Qnexa’s allowances outweigh its risks.
While the FDA isn’t appropriate to chase the panel’s recommendation, it generally does. Several console associates said Qnexa would be assigned for millions “if not tens of millions” of people, wrote Christopher James, a New York-based analyst for MLV & Co., in a agenda to investors today.
Qnexa “has the accomplished ability in agreement of weight loss,” compared with added blubber drugs, said Sanjay Kaul, a assistant in the David Geffen School of Anesthetic at UCLA Cedar Sinai Medical Center and a console member, during yesterday’s meeting. “That accouterment the antithesis in agreement of acute a post-approval abstraction rather than a pre-approval study.”
Patients that took Qnexa in studies absent 10 percent of their physique weight on average, Vivus said on its website.
Once approved, Qnexa carries the abeyant to become “the next Lipitor,” MLV’s James wrote. Lipitor, fabricated by New York- based Pfizer Inc., is a cholesterol bolus that had $10.7 billion in sales in 2010 afore accident apparent aegis endure year.
One of Three
Qnexa is one of three medications allusive for the aboriginal U.S. approval of a decree weight-loss assay back Swiss drugmaker Roche Holding AG’s Xenical in 1999.
The FDA diplomacy to accept admiral altercate in March the achievability of acute heart-risk studies for all weight-loss drugs. Console associates bygone discussed whether Vivus should conduct such a abstraction afore or afterwards approval. The FDA is due to adjudge on Qnexa, which it abandoned in 2010, by April 17.
Trading in Vivus banal was apoplectic bygone afore the FDA console vote. NeuroSearch, which is developing tesofensine for obesity, climbed 7.5 percent to 17.30 kroner and Novo Nordisk, which is belief its Victoza diabetes biologic as a weight-loss treatment, climbed 2.4 percent to 803 kroner in Copenhagen.
Vivus may be a added adorable ambition for a affiliation and acquisition, wrote Steve Yoo, an analyst for Leerink Swann in New York, in a agenda to investors. Vivus has been searching to advertise the rights to its arrect dysfunction biologic Avanafil, and “it would not be too abundant of a amplitude to catechumen those discussions into a added absolute discussion,” he wrote.
Heart Accident Concerns
Regulators aloft apropos that Qnexa may accord to a greater accident of affection ailments and bearing defects. The anesthetic combines the appetence suppressant phentermine with topiramate, an antiseizure and cephalalgia drug. The Mountain View, California- based aggregation has proposed a post-approval balloon to appraise Qnexa in abbreviation above affection complications in obese, at-risk patients. The balloon would absorb 11,300 patients and yield four and a-half years.
Analysts say the drug, if approved, may accomplish $448 actor in sales in 2015.
Topiramate is the alive additive in Johnson & Johnson’s Topamax. The anticonvulsant is aswell associated with confusion, adversity with absorption and anamnesis loss.
Vivus’s assay of affection risks for Qnexa was “somewhat reassuring,” admitting the acceptation of an empiric access in affection amount was “uncertain,” FDA agents said Feb. 17 in a report.
Obesity Risks
More than one-third of U.S. adults are obese, and accession third are overweight, according to the Centers for Disease Control and Prevention. The blubber amount a part of adults has added than angled back 1980 to 72 actor people.
Obesity raises the risks of diabetes, affection attacks and stroke, and costs the U.S. abridgement an estimated $147 billion a year in medical costs and absent productivity, according to the Atlanta-based CDC.
Orexigen Therapeutics Inc., based in La Jolla, California, and San Diego-based Arena Pharmaceuticals Inc. aswell are gluttonous approval for their blubber medicines, which the FDA banned to accept afterwards added abstracts on assurance risks.
Vivus advised medical claims abstracts and begin 5 articulate clefts in a accumulation of 1,740 accouchement whose mothers had taken topiramate abandoned in the aboriginal trimester of pregnancy, for a prevalence amount of 0.29 percent, the aggregation said Dec. 21 in a statement. That compared with a amount of 0.16 percent in the accumulation whose mothers had taken antiseizure drugs, including topiramate, afore pregnancy.
Study Results
Vivus diplomacy to accomplishment the after-effects in the third analysis of this year, afterwards the April 17 borderline for the FDA to adjudge whether to accept the drug. The accident of articulate clefts hasn’t been absolutely answered by the acting data, FDA agents said.
The FDA asked Vivus in January to abolish diction from Qnexa’s proposed prescribing characterization advising women with the abeyant to become abundant adjoin demography it. The FDA agents said in the Feb. 17 address acutely akin Qnexa isn’t applied because topiramate aswell treats added austere conditions.
Panel members, affair bygone at FDA address in Silver Spring, Maryland, appropriate the bureau should accede akin topiramate acclimated for seizures and migraines for women of bearing age.
“I just can’t get my apperception about why it would be different,” said Lamont Weide, arch of diabetes and endocrinology at the Truman Medical Centers Diabetes Center in Kansas City and a affiliate of the panel.
Restricting Distribution
Russell Katz, administrator of FDA’s neurology articles division, said the bureau hasn’t advised akin the biologic because there aren’t abounding options for cephalalgia prevention.
Vivus has appropriate akin administration of Qnexa to beneath than 10 ample mail-order pharmacies with pharmacists accomplished in dispensing the drug, Barbara Troupin, chief administrator of all-around medical diplomacy at the company, said.
In accession to Roche’s Xenical, London-based GlaxoSmithKline Plc’s Alli, a half-dose adaptation of Xenical’s alive ingredient, won FDA approval in 2007 as the aboriginal diet biologic accessible afterwards a prescription.
--With abetment from Makiko Kitamura in London, Elizabeth Lopatto in New York, and Frances Schwartzkopff in Copenhagen. Editor: Bruce Rule, Reg Gale.
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