FDA approves Sanofi’s Humalog follow-on Admelog
The Food and Drug Administration has given full approval to Sanofi’s Admelog short-acting insulin lispro — a follow-on of Eli Lilly’s Humalog. The product received tentative approval from the FDA earlier this year, and now it is the first short-acting follow-on product to get the FDA’s stamp of approval.
“One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives,” FDA commissioner Scott Gottlieb said. “This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient’s lifetime to manage a chronic disease. In the coming months, we’ll be taking additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe and effective alternatives to brand-name drugs approved through the agency’s abbreviated pathways.”
Admelog was approved under the FDA’s abbreviated approval pathway, in which a manufacturer submits an application that relies partly on the FDA’s finding of safety and efficacy of a reference drug — in this case, Humalog — to support its approval. The product is typically administered before a meal to help manage blood sugar levels after eating in patients with Type 1 diabetes — who typically also require a long-acting insulin, including insulin glargine, insulin degludec or insulin detemir, the FDA said.
"Sanofi has a deep heritage and broad experience in providing treatments for people living with diabetes,” Sanofi executive vice president and head of global diabetes and cardiovascular Stefan Oelrich said. “Complementing our existing insulin portfolio, Admelog will offer a more affordable option for those who require control of their blood sugar levels at mealtime. The approval of Admelog is an important milestone for Sanofi in our mission to serve patients living with chronic diseases such as diabetes.”
Sanofi said Admelog would be available in vials and the SoloStar pre-filled pen, which it said is the United States’ most-used disposable insulin pen platform. The FDA approval follows Admelog’s approval by the European Commission in July 2017 as a biosimilar.
Greenstone launches authorized Viagra generic
Pfizer subsidiary Greenstone has introduced its authorized generic of Viagra (sildenafil citrate). The Peapack, N.J.-based company said that its generic would be available in 25-, 50- and 100-mg dosage strengths.
The erectile dysfunction drug had a market size of roughly $1.4 billion for the 12 months ended August 2017, according to IQVIA data. Greenstone noted that as a Pfizer subsidiary, the company is backed by Pfizer’s distribution and customer service support.
Walgreens, NewYork-Presbyterian partner on Duane Reade telehealth kiosks, online access
Walgreens is making a push to bring telemedicine services to stores through a new partnership with NewYork-Presbyterian. The partnership will bring access to telehealth services from New York’s top hospital via NYP OnDemand kiosks for shoppers at the Deerfield, Ill.-based retailer’s Duane Reade banner, as well as through its digital properties.
“We are delighted to work with Walgreens to bring NewYork-Presbyterian’s world-class care right to your neighborhood drugstore with this exciting new platform,” NewYork-Presbyterian president and CEO Steven Corwin said. “Patients can expect to receive focused, one-on-one care from leading physicians, where and when they need it. We believe telemedicine has a critical role to play in expanding access to high-quality care, and we are proud to be at the forefront of digital health care delivery.”
The first NYP OnDemand kiosk has been installed at Duane Reade’s 40 Wall St. location in Manhattan, with additional kiosks set to follow in 2018. The kiosks are located in private, secure rooms at the stores, where patients can receive an instant exam, diagnosis and treatment through NewYork-Presbyterian’s NYP OnDemand Urgent Care. Any prescriptions written can be electronically sent to a patient’s preferred pharmacy, the companies said.
Walgreens noted that pediatric emergency physicians also will be available, but with more limited hours. Currently, patients will reach emergency medicine physicians from Weill Cornell Medicine, with physicians from ColumbiaDoctors expected to join in early 2018, Walgreens said
“These kiosks provide real-time care for our patients, enabling them to consult Weill Cornell Medicine physicians privately through the convenience of their local drugstores,” said Dr. Augustine M.K. Choi, the Stephen and Suzanne Weiss Dean of Weill Cornell Medicine. “We are proud to work with NewYork-Presbyterian and Walgreens to extend the reach of our doctors beyond their offices, making healthcare accessible to patients across the city.”
Beyond the kiosks, New York-area patients will be able to access NYP OnDemand Urgent Care telehealth services through the Walgreens website.
“We’ve had much success over the years working with NewYork-Presbyterian at our on-site Walgreens pharmacy,” Walgreens Healthcare Clinics chief medical officer Pat Carroll said. “We value this innovative collaboration and look forward to finding new and different ways to work together to enhance patient care.”