FDA warning about counterfeit Alli

If you buy Alli, make sure you're getting the real product. The FDA is warning consumers about counterfeit Alli.

Preliminary laboratory tests conducted by GlaxoSmithKline (GSK)—the maker of the FDA approved over-the-counter weight-loss product— revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight.  Sibutramine can also interact in a harmful way with other medications the consumer may be taking.

Learn more by reading the recent FDA press release here.

Arzerra (ofatumumab) for CLL approved by the FDA

FDA NEWS RELEASE

For Immediate Release: Oct. 26, 2009

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves New Treatment for Chronic Lymphocytic Leukemia

The U.S. Food and Drug Administration today approved Arzerra (ofatumumab) for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone marrow.

Arzerra is approved for patients with CLL whose cancer is no longer being controlled by other forms of chemotherapy.

CLL primarily affects people older than 50 and arises from a group of white blood cells known as B-cells that are part of the body’s immune system. Each year, about 16,000 people are diagnosed with CLL and about 4,400 people die from the disease.

Arzerra is a monoclonal antibody, a type of biotechnology product. Antibodies that occur in nature are produced by the immune system in response to invaders. Arzerra binds to a specific protein found on the surface of both normal and malignant B cells, making the cells more susceptible to immune system attack.

The product was approved under the FDA’s accelerated approval process, which allows earlier approval of drugs that meet unmet medical needs. Products may receive accelerated approval based on a surrogate endpoint, such as a reduction in the size of the tumor or decrease in the number of cancerous white cells or in an enlarged spleen or lymph nodes. These indirect measures for clinical outcomes are considered reasonably likely to predict that the drug will allow patients to live longer or with fewer side effects of a disease.

“The approval of Arzerra illustrates FDA's commitment to using the accelerated approval process to approve drugs for patients who have limited therapeutic options,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research.

The accelerated approval process requires further study of the drug. The manufacturer is currently conducting a clinical trial in CLL patients to confirm that the addition of Arzerra to standard chemotherapy delays the progression of the disease.

Arzerra's effectiveness was evaluated in 59 patients with CLL whose disease no longer responded to the available therapies.

The product’s safety was evaluated in 181 patients in two studies in patients with cancer. Common side effects included a decrease in normal white blood cells, pneumonia, fever, cough, diarrhea, lower red blood cell counts, fatigue, shortness of breath, rash, nausea, bronchitis and upper respiratory tract infections.

The most serious side effects of Arzerra are increased chance of infections, including progressive multifocal leukoencephalopathy (PML), a brain infection that is generally fatal. Patients at high risk for Hepatitis B should be screened before being treated with Arzerra. Patients with evidence of inactive hepatitis should be monitored for re-activation of the infection during and after completing treatment.

Arzerra is manufactured by London-based GlaxoSmithKline.

Votrient (pazopanib) approved for advanced kidney cancer

Votrient (pazopanib) has been approved by the FDA for the treatment of advanced kidney cancer. Votrient is made by GlaxoSmithKline (GSK).

• The U.S. Food and Drug Administration today approved Votrient (pazopanib), the sixth drug to be approved for kidney cancer since 2005.
• Votrient is an oral medication that interferes with angiogenesis, the growth of new blood vessels needed for solid tumors to grow and survive.
• Votrient is intended for people with advanced renal cell carcinoma, a type of kidney cancer in which the cancerous cells are found in the lining of very small tubes (tubules) in the kidney. In 2009, approximately 49,000 people were diagnosed with renal cell carcinoma and 11,000 people died from the disease.

Click here to read the FDA press release.

FDA approves Cervarix

The FDA has approved Cervarix, a new cervical cancer vaccine. The current vaccine Gardasil is made by Merck and Cervarix is made by GlaxoSmithKline (GSK).

The FDA has approved CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

Click here to read the press release on the GSK website.

Arzerra (ofatumumab) appears promising for CLL

Arzerra (ofatumumab) appears promising for chronic lymphocytic leukemia (CLL). Ofatumumab (formerly known as HuMax-CD20) is a targeted therapy. It is actually a human monoclonal antibody that targets a distinct antibody binding site (the small loop epitope) of the CD20 molecule on the cell membrane of B cells. It is currently under development for the treatment of CLL and has also shown potential in treating follicular non-Hodgkin’s lymphoma, diffuse large B cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis. Is it available yet? No. The FDA is currently still reviewing this biologic agent. Here's a snippet from the June GSK press release:

GlaxoSmithKline and Genmab A/S today announced that the United States Food and Drug Administration (FDA) informed the companies that the agency has extended the action date for the ofatumumab BLA application by three months.

The FDA has been slow recently, don't you think? Better safe than sorry? Or, is the FDA being overly-cautious? We don't want to see another Raptiva incident again, do we? Raptiva was voluntarily withdrawn in April by Genentech because of an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system. It's difficult to find such rare adverse effects until the drug gets used by the public, so I don't think anyone is faulting either the FDA or Genentech.

Well, let's see what happens with ofatumumab.

FDA: Boxed warning for Chantix and Zyban

FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban

The U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

The FDA press release has this comment from Janet Woodcock, M.D., director, the FDA’s Center for Drug Evaluation and Research: “The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking... Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”

Wellbutrin (another branded name of bupropion) and generic versions of bupropion will also require this warning. Chantix is marketed by Pfizer and Zyban is marketed by GlaxoSmithKline (GSK). Before we know it, every drug out there will have a black box warning and people might simply start to ignore them. Will we soon need another form of a boxed warning?

What Do You Think About Rezonic/Zunrisa (Casopitant)?

Rezonic/Zunrisa (Casopitant) is a new drug that's being developed by GlaxoSmithKline (GSK). The indications will be for:

• Treatment for Nausea/Vomiting -- Chemotherapy Induced
• Nausea/Vomiting -- Postoperative

How does it compare to Merck's Emend (aprepitant), which is also an NK-1? Get familiar with the results of an ASCO 2008 abstract titled, "Phase III results for the novel neurokinin-1 (NK-1) receptor antagonist, casopitant: Single oral dosing regimen for chemotherapy-induced nausea and vomiting (CINV) in patients (Pts) receiving highly emetogenic chemotherapy (HEC)." That's quite a title.

The conclusion is simple: A single oral dose of casopitant added to a regimen of OND/DEX provided a clinically significant reduction in the number of pts experiencing CINV events over the first 5 days after HEC. This benefit appeared to be maintained through repeat cycles. This regimen was generally well tolerated over all cycles.

Deirdre Connelly Leaves Eli Lilly for GSK

Lot's of movement in pharma. One of the most recent headlines:

Deirdre Connelly Leaves Eli Lilly for GSK

What do you think about that? Deirdre Connelly was named one of the 50 most powerful women by Fortune Magazine. In 2007, her rank was 47. In 2008, her rank moved to 42. What will it be for 2009?