It promises to be another blockbuster for Eli Lilly and Co.
The Food and Drug Administration (FDA) has approved the company’s new drug, Symbyax, for treatment-resistant bipolar depression.
The new drug combines the active ingredients in Zyprexa and Prozac, giving Lilly a way around the patent expiration of Prozac.
This is the first drug approved by the FDA for depression that has not successfully been treated in at least two previous attempts.
Symbyax will carry a warning about weight gain, hyperglycemia (high blood sugar) which can turn into diabetes, and hyperlipidemia (elevated lipids in the bloodstream including cholesterol).
While Prozac or fluoxetine lost its patent protection and blockbuster profits for Lilly, Zyprexa or olanzapine, has had a series of bad press, mainly because of its link to diabetes. It has also faced competition from generics overseas.
Eli Lilly had to pay the federal government more than $1.4 billion to settle an off-label marketing scheme for its prescription drug, Zyprexa.
The settlement was the largest amount paid by a single defendant in the history of the U.S. Department of Justice.
IB member attorney Stephen Sheller filed the first complaint in February 2003. The allegations originated from six former Lilly drug marketing representatives who became whistleblowers.
“They reported what they felt was very wrong and tried to do it first within the company boundaries, but no one was interested in hearing that,” says Jamie Sheller of Sheller P.C.
And patients should be aware of the latest findings in the New England Journal of Medicine.
Patients taking a newer group of atypical antipsychotics are twice as likely to suffer sudden cardiac failure and death as nonusers, the study finds. The convention wisdom was the newer antipsychotics were safer than the older ones.
Atypicals include AstraZeneca’s Seroquel, Eli Lilly’s Zyprexa, Johnson & Johnson’s Risperdal and Novartis’s Clozaril.
An accompanying editorial says we should reduce the use of atypical drugs in children and elderly patients. #