The US Food and Drug Administration (FDA) has approved a combination vaccine that offers protection against diphtheria, tetanus, pertussis, and polio in a single shot; and the use of methyl aminolevulinate 16.8% cream with a narrow-band, red-light device equipped with light-emitting diodes for the treatment of actinic keratoses.
KINRIX Combines INFANRIX and PEDIARIX Components for Children Aged 4 to 6 Years
On June 24, the FDA approved diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine (KINRIX; GlaxoSmithKline Biologicals) for active immunization as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series.
The new vaccine combines the DTaP and IPV components of INFANRIX and PEDIARIX, respectively, and is indicated for children aged 4 to 6 years who have previously received 3 doses of the INFANRIX or PEDIARIX series and INFANRIX for the fourth dose (both made by GlaxoSmithKline Biologicals).
"Children 4 to 6 years old can receive 5 or more vaccinations in a single visit, which can be stressful for parents and vaccinators," said William P. Hitchcock, MD, assistant clinical professor of pediatrics at the University of California, San Diego School of Medicine. "By reducing the number of shots given in 1 visit, combination vaccines like KINRIX may make it easier for kids to meet school vaccination requirements and CDC [Centers for Disease Control and Prevention] recommendations."
The approval was based on data from a randomized controlled, pivotal phase 3 trial (N = 3156), demonstrating that the new combination vaccine offers similar protection and a safety profile comparable to separately administered DTaP and IPV vaccines.
Local adverse events related to vaccination with KINRIX vs INFANRIX plus IPV in children also receiving their second dose of measles, mumps, and rubella vaccine (Merck and Company, Inc) included pain (57% vs 53.5%), erythema (36.6% for both), increased arm circumference (36% vs 37.8%), and swelling (26% vs 27%). General effects included drowsiness (19.1% vs 17.5%), fever of 99.5 °F or more (16.0% vs 14.8%), and loss of appetite (15.5% vs 16%).
Aminolevulinate Cream (Metvixia) Approved for Use With New PDT Lamp
On June 26, the FDA approved a revised indication for methyl aminolevulinate 16.8% cream (Metvixia; PhotoCure, ASA), allowing its use in combination with the company's new red-light lamp (Aktilite CL238; PhotoCure, ASA) for the photodynamic treatment (PDT) of thin and moderately thick, nonhyperkeratotic, nonpigmented actinic keratoses of the face and scalp in immunocompetent patients.
The new lamp is equipped with light-emitting diodes and emits red light with a narrow spectrum at approximately 630 nm and a half-width of approximately 20 nm. The light dose is 37 J/cm2, and the lamp should be placed 50 to 80 mm from the skin.
Previously, the product was approved for use with the company's CureLight BroadBand (Model CureLight 01) lamp, which produces a red light of 570- to 670-nm wavelength at 75 J/cm2.
The approval was based primarily on data from 2 multicenter, randomized, double-blind, vehicle-controlled studies of 211 patients with a total of 1555 nonhyperkeratotic actinic lesions who were randomized to receive PDT with methyl aminolevulinate or placebo cream on 2 occasions 1 week apart.
Each PDT session consisted of lesion preparation (debridement with a sharp curette) to roughen the surface, application of methyl aminolevulinate or vehicle cream with subsequent maintenance under occlusion for 3 hours, and removal of residual cream followed immediately by red-light activation.
Results 3 months after treatment showed that use of methyl aminolevulinate/PDT was significantly more effective than vehicle/PDT to achieve complete response (CR), defined as complete disappearance of all lesions on visual inspection and palpation (first study, 59.2% vs 14.9%; second study, 68.4% vs 6.9%).
Furthermore, methyl aminolevulinate/PDT therapy achieved similar mean rates of clearance for grade 1 lesions of the face and scalp (CR, 89% and 90%). Corresponding clearance rates for grade 2 lesions were 86% and 75%, respectively.
In the 2 studies, adverse reactions such as headache, pain, or burning led to discontinuation of therapy in 4.8% (6 of 126) patients receiving methyl aminolevulinate/PDT; 12 patients required pausing of illumination because of pain, burning, or stinging but did subsequently complete treatment.
Adverse events most commonly reported (incidence ≥ 10%) in patients receiving methyl aminolevulinate vs vehicle cream for PDT included skin burning, pain, or discomfort (86% vs 36%); erythema (63% vs 10%); scabbing, crusting, blister, or erosions (29% vs 1%); pruritus (22% vs 8%); skin or eyelid edema (18% vs 1%); and skin exfoliation (14% vs 3%). Discharge at the application site and skin hemorrhage, tightness, or hyperpigmentation were relatively rare (incidence, 2% each).
KINRIX Prescribing Information
KINRIX Prescribing Information
Metvixia Prescribing Information
Metvixia Prescribing Information
Pearls for Practice
The FDA has approved a combination vaccine for active immunization as the fifth dose in the diphtheria, tetanus, and acellular pertussis vaccine series and the fourth dose in the inactivated poliovirus vaccine series. It is indicated for use in children aged 4 to 6 years and has been shown to be as safe and effective as separately administered diphtheria, tetanus, and acellular pertussis and inactivated poliovirus vaccine shots while reducing the number of injections by 1.
Methyl aminolevulinate with a new lamp equipped with light-emitting diodes has been approved for the photodynamic treatment of certain actinic keratoses on the face and scalp. Complete response (clearance) of all lesions occurred in 59.2% and 68.4% of patients, respectively, in 2 studies. Similar rates of clearance occurred for grade 1 lesions of the face (89%) and scalp (90%). Corresponding clearance rates for grade 2 lesions were 86% and 75%, respectively.
Reviewed by Ramaz Mitaishvili, MD
