FDA News & Approvals
First Blood Test for Anthrax Approved
Immunetics Inc., announced that the FDA approved the company’s blood test for anthrax infection, which is the first of its kind approved for use on patient blood specimens. This new test operates by detection of antibodies to a key component of the anthrax bacillus, which forms part of the toxin responsible for its deadly effects. The test was shown to detect 100% of anthrax patients tested in clinical trials, and was able to detect both inhalational and cutaneous anthrax. Clinical trials showed the test had less than a 1% chance for false positive readings.
This test can be used by any clinical or public health lab without the need for specialized equipment or training.

New Generics Approved
The FDA approved two first-time generic drugs in June. Generic versions of metronidazole topical cream 0.75% for the treatment of inflammatory papules and pustules of rosacea was approved. Also, a generic itraconazole capsule 100 mg., as an antifungal, was approved.

Orphan Drug Designation Granted
Medarex Inc., announced that the FDA granted orphan drug designation to its fully human anti-CTLA-4 antibody, MDX-010, for the treatment of high-risk Stage II, Stage III and Stage IV melanoma. Orphan designation is granted for treatments that offer potential therapeutic value for diseases that affect fewer than 200,000 people in the United States. It also provides eligibility for a special 7-year period of market exclusivity upon approval, potential tax credits for research, grant funding for research and development, reduced filing fees for marketing applications and assistance with the review of clinical trial protocols.

Pending approval on a Special Protocol Assessment application that has been filed, Medarex expects to initiate a study for MDX-010 in combination with a gp 100 melanoma vaccine later this year. Results from a Phase II trial with MDX-010 alone and in combination with dacarbazine (DTIC-Dome) for the treatment of metastatic melanoma were positive, showing a 17.1% response rate (six of 35 patients) of complete and partial responses in patients with metastatic melanoma.

Another Phase II study conducted last year found a 21.4% response rate (three of 14 patients) in metastatic melanoma patients treated with a high 3 mg/kg dose of MDX-010 in combination with gp 100 peptide vaccine. In this trial, patients who experienced complete and partial responses still remain cancer-free more than 20 months later. Diarrhea and rash have been the most common adverse events reported.

MDX-010 is also being tested in a Phase II chemotherapy combination clinical trial for prostate cancer and is being studied as a monotherapy in a Phase II clinical trial for breast cancer and Phase I clinical trial for HIV.

Approval for Laser
The FDA granted Section 510(k) premarket approval to the Dual Yellow D10B Laser for the treatment of benign pigmented and cutaneous vascular lesion. The device, manufactured by Norseld of South Australia, is a copper bromide laser, which emits energy at 511 nm and 578 nm. The device consists of a cabinet, fiber optic delivery system and a user/software interface.

IPL Systems Approved
Cynosure’s Photosilk and Photosilk Plus were granted Section 510(k) premarket approval by the FDA for permanent hair reduction and treatment of benign vascular and pigmented lesions.

Photosilk and Photosilk Plus are intense pulsed light systems with a Xenon flashlamp located in the handpieces. They have a wavelength range of 400 nm to 1200 nm. Light emission activation is by foot switch.

Skin cooling is provided by the integrated cooling handpiece that contains cooled water circulated through the handpiece body, the face of which is in contact with the skin.

WaveLight Lasers
The Sinon laser system, manufactured by WaveLight Laser Technologie of Germany, was granted 510(k) premarket approval by the FDA. The Sinon, a 694 nm Ruby laser system, can be operated in two different modes. In its Q-switched mode, it’s indicated for cutting, vaporization or ablation of soft tissue, such as removal of tattoos and treatment of benign pigmented lesions. In its free-running mode, its indicated for the removal of unwanted hair in patients with skin types I and II.

Also manufactured by WaveLight Laser Technologie, the Mydon C laser system, a 1064 nm solid-state long-pulsed Nd:YAG laser system, was granted 510(k) premarket approval by the FDA. With this laser, the beam is directed to the treatment area by a transmission system, which is connected to the laser device and consists of a multifunction hose system and a tightly connected hand unit. In the hose system, both laser radiation carrying quartz fiber and the cooling and signal leads are contained.

The Mydon C transmission system includes skin cooling integrated into the hand unit and cools the area of the skin that the laser covers. The hand unit cooling system cools the treatment area before, during and after the laser pulse in a single step. The hand unit inserts allow for various treatment types and parameter ranges. The system offers the 1.5-mm and 3-mm hand unit inserts specifically for the treatment of vascular lesions, the 5-mm hand unit insert for the treatment of vascular lesions and wrinkles, and the 7-mm and 10-mm hand unit inserts for hair removal.

PhotoMedex Approvals
The FDA granted 510(k) premarket approval to the PhotoMedex LaserPro 810, 940 and 980 diode laser systems, and the fiber delivery systems and accessories that are used with them to deliver laser energy. The laser systems are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision and coagulation of soft tissue.

Is there a Link Between Psoriasis and Female Hormones?
C ould a potential cause of psoriasis, atopic dermatitis or some of the other dermatologic conditions that are autoimmune in nature have a connection to certain hormone levels?

A new study may shed light on this possible connection between estrogen levels and the incidence and severity of autoimmune diseases.

A Baylor College of Dentistry study looked at cell cultures to examine the specific pathways where estrogen interacts with immune cells. The researchers found that a decrease in estrogen levels resulted in an increase in CD16 levels. CD16 is a molecule of the cell surface that regulates inflammation. The increase in this molecule starts a chain reaction of inflammation affecting joints and organ tissues.

According to researchers, changes in estrogen can make women more vulnerable to inflammatory auto-immune diseases, such as rheumatoid arthritis. They also found that changes in estrogen can also increase the severity of symptoms of these diseases.

Further study into the role of estrogen on the incidence and severity of autoimmune diseases among women is still needed, the study found.