Allergan Obtains FDA Clearance To Treat Area Below Jawline With CoolSculpting

(RTTNews) - Allergan plc (AGN) said that the CoolSculpting treatment received FDA clearance to treat the submandibular area.

In addition, the FDA clearance was expanded to includ patients with a BMI of up to 46.2 when treating the submental and submandibular areas. The recent clearance makes CoolSculpting the first and only nonsurgical fat reduction treatment to contour the area below the jawline and improve the appearance of lax tissue in conjunction with submental fat treatments, the company said.

The efficacy of the CoolSculpting treatment in the area right below the jawline was proven in a 22-week clinical study, which demonstrated an average 33 percent reduction in fat layer thickness after two treatments. Additionally, an average 85 percent patient satisfaction rate was reported across three studies.

Earlier today, Aegon's subsidiary Transamerica announced an agreement that would resolve litigation challenging certain monthly deduction rate adjustments on universal life insurance policies in the United States. The settlement for an amount of US$195 million removes the uncertainty of ongoing litigation for the company and its customers.

Transamerica's universal life insurance policies permit the company to adjust monthly deduction rates up to a contractually guaranteed maximum, subject to certain conditions. Plaintiffs in lawsuits challenged increases to monthly deduction rates on approximately 70,000 universal life policies that were enacted in 2015 and 2016. Transamerica implemented these adjustments, necessitated by low long-term interest rates, changes in expectations as to future mortality experience, and other factors, and in accordance with the policies' contractual terms.

The agreement creates a settlement class of all Transamerica policyholders that were subject to the 2015 and 2016 monthly deduction rate adjustments. The settlement will be filed with the United States District Court for the Central District of California on or about October 4, 2018, and is subject to court approval. Impacted policyholders will receive notice approved by the court with details of the settlement.

As per the terms of the settlement agreement, Transamerica will pay the settlement amount into a common fund, and absorb additional costs for attorneys' fees, class notice and administration. The capital and pre-tax IFRS impacts are expected to be in the range of the amount of the settlement.