The blockbuster type 2 diabetes drug Avandia raises users' odds for heart attack and heart failure and should be removed from the market, according to confidential government reports.

The New York Times on Saturday reported on documents from the U.S. Food and Drug Administration that find that if people now taking (rosiglitazone) Avandia switched to a similar medication, Actos, about 500 heart attacks and 300 cases of heart failure would be eliminated each month. And in a report from the Institute for Safe Medication Practice, Avandia was linked to 304 deaths in the third quarter of 2009 alone, the highest for any prescribed drug in that time period, the Times reported.

Novartis announced that Menveo (Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine), a quadrivalent meningococcal conjugate vaccine, was approved by the FDA for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in people 11 to 55 years of age.

FDA approval of Menveo was based on a Phase III head-to-head clinical trial that compared Menveo to the other US-licensed ACWY meningococcal conjugate vaccine among subjects 11 to 55 years of age.

The trial, which was broken into two subsets - adolescents, age 11 to 18 and adults, age 19 to 55 - measured for each of the four serogroups both the percentage of subjects who achieved an immune response as measured by seroresponse and proportions achieving human serum bactericidal antibody (hSBA) titers >=1:8. Additionally the study examined antibody level as measured by geometric mean titers (GMT).

In study participants aged 11 to 18 years, Menveo met its primary endpoint for all four serogroups using hSBA seroresponse. The percentages of subjects who demonstrated an immune response (ie, achieved an hSBA titer >=1:8) for each serogroup for Menveo and its comparator (the other currently US-licensed ACWY meningococcal conjugate vaccine) respectively, were: Serogroup A - 75: 67; serogroup C - 84: 84; serogroup Y - 88: 69; and serogroup W-135 - 96: 88.

The seroresponse with Menveo for serogroups A, Y and W-135, was statistically higher. However the clinical relevance of higher post-vaccination immune responses is not known.

In the same group, the levels of circulating antibodies (ie, GMT) in those who received Menveo vs those who received the comparator, respectively were: Serogroup A - 29: 18; serogroup C - 59: 47; serogroup Y - 51: 18; and serogroup W-135 - 87: 44.

Andrin Oswald, division head of Novartis Vaccines and Diagnostics, said: "The FDA approval of Menveo is an important milestone for adolescent immunization in the United States. According to CDC estimates, approximately 16 million adolescents between the ages of 11 and 18 are at risk and remain unprotected against meningococcal disease. Meningococcal disease is particularly distressing because it can rapidly kill or debilitate previously healthy adolescents. For this reason, we are dedicated to helping eradicate meningococcal disease in the United States and around the world."

Keith Reisinger, MD, medical director at primary physicians research in Pennsylvania, said: "Even with early and appropriate treatment, patients can die from meningococcal disease, often within 24-48 hours of onset of symptoms6.

Menveo achieved a higher immune response than the other currently available vaccine, which is very reassuring. With the FDA approval of Menveo, now healthcare providers in the United States have another option to help prevent this life-threatening invasive disease."