AbbVie settles insurance fraud suit, agrees to tweak nurse ambassador program; CStone aims for NSCLC OK with positive PhIII data
AbbVie has resolved a California lawsuit alleging insurance fraud in the promotion of its cash cow Humira, paying $24 million to settle things with the state’s insurance regulator.
The settlement comes almost four years after a whistleblower first reported AbbVie’s practice of deploying registered nurses to visit patients at home or call them by phone to ensure that Humira prescriptions are filled. AbbVie was also charged with providing illegal kickbacks to doctors in an attempt to encourage them to prescribe Humira for a range of anti-inflammatory diseases.
The company denied any wrongdoing, and told Reuters that the nurse ambassador program will continue with no significant changes. Its argument has long been that they are simply prodiving education and support services for patients.
It did, however, agree to review some of its marketing practices. Among other things, the ambassadors will now disclose to patients that they work with AbbVie and won’t be allowed to discuss specific patients with doctors or insurance companies. Humira sales reps will also be prohibited from inviting prescribing health care providers to offsite business meals.
“AbbVie’s prior practices in marketing Humira egregiously put profits ahead of transparency in patient care and violated California law,” said California insurance commissioner Ricardo Lara in a statement. “This settlement delivers important reforms to AbbVie’s business practices and a substantial monetary recovery that will be used to continue to combat insurance fraud.” — Amber Tong
Eyeing lucrative NSCLC market, CStone reports positive PhIII data
CStone is on its way toward breaking into the big non-small cell lung cancer market.
The Chinese biotech released interim data from a Phase III trial Friday morning showing that its anti-PD-L1 candidate CS1001, combined with platinum-based chemotherapy, met its primary endpoint for the first-line treatment of stage IV squamous and non-squamous NSCLC. The average progression-free survival was 7.8 months for patients using the combo versus 4.9 months with only chemotherapy.
Other key data highlights included a well-tolerated profile with no new safety signal detected.
Checkpoint inhibitors for lung cancer have already hit the market in China, with AstraZeneca’s PD-L1 Imfinzi joining the PD-1s made by Merck and Bristol Myers Squibb late last year. Weeks later, Roche scored a PD-L1 greenlight for Tecentriq for the treatment of small cell lung cancer.
But as Innovent, Junshi and Hengrui have shown, domestic drug developers are more than willing to compete on price. Should CStone’s candidate gain approval, it could still shift the landscape considerably. — Max Gelman
FDA approves Bayer’s new formulation of old Chagas disease drug
Bayer’s new formulation of nifurtimox, an older drug used to treat Chagas disease, has been approved by US regulators.
The FDA green-lit Lampit on Friday morning for use in newborns and children under 18. Lampit, an antiprotozoal medication, will be available in a new, dividable tablet that can be split by hand and is designed to disperse in water for those too young to swallow. Patients on Lampit will take a treatment regimen for 60 days.
Spread by insect bites and caused by the parasite Trypanosoma cruzi, Chagas disease can cause congestive heart failure if left untreated. The drug received accelerated approval based on the number of patients who became IgG negative or who showed an at least 20% decrease in optical density on two different antibody tests.
Bayer is expected to continue Phase III trials over the next three years to confirm efficacy and safety. — Max Gelman