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Boehringer Ingelheim gains orphan drug status for volasertib for the treatment of acute myeloid leukemia

BY Michael Johnsen

RIDGEFIELD, Conn. — Boehringer Ingelheim Pharmaceuticals has announced that the Food and Drug Administration and European Commission have granted Orphan Drug Designation to volasertib for acute myeloid leukemia. Volasertib currently is being evaluated in a Phase III clinical trial for the treatment of patients ages 65 years or older with previously untreated AML who are ineligible for intensive remission induction therapy. 

Volasertib has not been approved by the FDA or EC regulatory authorities; its safety and efficacy have not been established.

AML is an aggressive cancer of the bone marrow and blood. It accounts for approximately one-third of all adult leukemias in the Western world, and has one of the lowest survival rates of all leukemias. AML primarily is a disease of later adulthood; the average age of an AML patient is 65 years to 70 years. The recommended standard of care currently is intensive chemotherapy, but many patients, due to age and comorbidities, cannot tolerate this therapeutic approach. For them, options are limited, and their prognosis typically is poor. Volasertib currently is being investigated in this specific patient population.

"The FDA and EC Orphan Drug Designations mark an important milestone in our global development program for volasertib," said Sabine Luik, SVP medicine and regulatory affairs, Boehringer Ingelheim Pharmaceuticals. "Boehringer Ingelheim is deeply committed to supporting the community of patients living with acute myeloid leukemia, with a current research focus on these older patients who have very limited treatment options." 

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FDA approves ofatumumab/chlorambucil combo treatment for chronic lymphocytic leukemia

BY Michael Johnsen

LONDON — GlaxoSmithKline and Genmab A/S announced last week that the Food and Drug Administration has approved a supplemental biologic license application for the use of Arzerra (ofatumumab) in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia for whom fludarabine-based therapy is considered inappropriate.

The FDA approval of the first-line indication is based on results from a Phase III study (Complement 1), which demonstrated statistically significant improvement in median progression-free survival in patients who received the combination of ofatumumab and chlorambucil compared to patients who received chlorambucil alone.

“CLL is the most common form of leukemia amongst adults in Western countries, many of whom are elderly with multiple health issues,” said Paolo Paoletti, president of Oncology, GSK. “Today’s approval by the FDA for the use of Arzerra in the first-line setting means that appropriate patients with CLL have a new treatment option.”

“We are pleased that Arzerra has been shown to provide clinical benefit and will now be available in the first-line setting. Arzerra, the first approved therapeutic created by Genmab and developed in collaboration with GSK, is the only therapeutic CD20 antibody approved in combination with chlorambucil for first-line CLL and as a monotherapy for CLL refractory to fludarabine and alemtuzumab,” said Jan van de Winkel, CEO Genmab.

 

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MD Science Lab introduces Swiss Navy Sensitive Skin personal lubricant

BY Michael Johnsen

POMPANO BEACH, Fla. — MD Science Lab on Monday launched a new personal lubricant called Swiss Navy Sensitive Skin. The new, all-natural lubricant caters to men and woman with sensitive skin.

"Our research indicated that there was a great demand for a lubricant that was not only formulated for sensitive skin but clearly stated it on the packaging," said Ralph Albrecht, MD Science Lab founder. "Shopping for lubricants is confusing enough for consumers, without expecting them to research ingredients before shopping. We are just taking the guesswork out of it and offering a product that feels great." 

Swiss Navy Sensitive Skin contains carrageenan, a seawater-based gelatin that is silkier than water and feels like the popular lubricant ingredient silicone. It is glycerin-, paraben- and sugar-free, all natural and vegan, and it leaves skin feeling soft. Swiss Navy Sensitive Skin is available in a 4-oz. bottle.

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