FDA Approval of Ipilimumab
The FDA has approved Yervoy (ipilimumab) to treat patients with late-stage (metastatic) melanoma after a successful study showed increased survival time.
The study enrolled 676 patients with non-removable melanoma. All patients in the study had stopped responding to other treatments for melanoma. The randomly assigned patients received either Yervoy, Yervoy with an experimental tumor vaccine called gp100, or just gp100. Patients that received Yervoy alone or in combination lived an average of about 10 months post-treatment, while those that received only the experimental vaccine lived an average of 6.5 months post-treatment.
Yervoy is a monoclonal antibody that blocks a molecule known as cytotoxic T-lymphocyte antigen or CTLA-4. CTLA-4 may play a role in slowing down or turning off the body's immune system, affecting its ability to fight off cancerous cells. Yervoy may work by allowing the body's immune system to recognize, target and attack cells in melanoma tumors. The drug is administered intravenously.
Common side effects that can result from autoimmune reactions associated with Yervoy use include fatigue, diarrhea, skin rash, endocrine deficiencies (gland or hormone) and inflammation of the intestines (colitis). Severe to fatal autoimmune reactions were seen in 12.9 percent of patients treated with Yervoy. When severe side effects occurred, Yervoy was stopped and corticosteroid treatment was started. Not all patients responded to this treatment. Patients who did respond in some cases did not see any improvement for several weeks.
Due to the unusual and severe side effects associated with Yervoy, the therapy is being approved with a Risk Evaluation and Mitigation Strategy to inform health care professionals about these serious risks. A medication guide will also be provided to patients to inform them about the therapy's potential side effects.
Yervoy is marketed by Bristol-Myers Squibb.
FDA Warning Letter
Jaba Labs LLC, makers of StemCellin Intensive Emulsion, StemCellin Deep Wrinkle Serum and Faitoz-25, has received a warning letter from the FDA for Jaba Labs' marketing of its drugs without approval from the FDA.
Upon review of the claims and testimonials included in Jaba Labs' websites, http://www.stemcellfacecream.com and http://www.synovialabs.com, the FDA determined that StemCellin Intensive Emulsion, StemCellin Deep Wrinkle Serum, and Faitoz- 25 are drugs because they are intended to affect the structure or function of the human body. In its letter, the FDA explains that the products are not generally recognized as safe and effective for the intended uses and are, therefore, "new drugs." The FDA further explains that a new drug may not be legally marketed in the U.S. without prior approval from FDA which requires scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
FDA Approves Zyclara Cream, 3.75% for Treatment of External Genital Warts
Graceway Pharmaceuticals announced today that the FDA has approved Zyclara Cream for the treatment of external genital and perianal warts (EGW) in patients 12 years of age and older. Zyclara Cream's clinical studies demonstrated that using its once-daily treatment regimen, for up to eight weeks, safely and effectively clears genital warts. In addition, data showed that of those patients who achieved complete clearance, only a small number experienced a recurrence of their warts 12 weeks after treatment.
Two Phase III double-blind, placebo-controlled efficacy and safety studies of imiquimod 3.75% cream evaluated complete clearance of all warts warts — defined as clearance of baseline and emergent warts — across several anatomical locations. In an intent-to-treat analysis of all participants who began the study, regardless of whether they completed it, complete clearance of all warts was achieved in 28.3 percent of patients on imiquimod 3.75% cream, compared to 9.4 percent on placebo cream. Additionally, efficacy was greater in females than males for all primary and secondary efficacy measurements, and 37 percent of females on the 3.75% formulation achieved complete clearance compared to 19 percent of males.
In subjects with complete clearance only 15 percent treated with imiquimod 3.75% cream experienced a recurrence of their warts within 12 weeks.
Zyclara Cream was developed to meet the need for a shorter treatment regimen, while maintaining the efficacy (both initial and sustained clearance) of imiquimod.