Mylan to launch 2 HIV treatments
Mylan will soon be bringing its recently approved HIV medications Symfi Lo and Cimduo to market. The company on Friday said Symfi Lo would become available in the coming weeks, with Cimduo’s launch anticipated in the second quarter. Mylan said that the launches are aimed at reducing the cost of HIV treatments, which is more than $20 billion annually, according to IQVIA data.
“As the world’s largest supplier of antiretrovirals by volume, Mylan is deeply committed to expanding access to treatment for people living with HIV,” said Mylan CEO Heather Bresch. “For a decade, we have helped transform the level of access to high-quality, affordable HIV medications in developing countries. We are excited to bring that same passion to the U.S. with the upcoming launches of Symfi Lo and Cimduo and help deliver significant savings to the healthcare system.”
Symfi Lo (efavirenz, lamivudine 400 mg and tenofovir disoproxil fumarate 300 mg) is a once-daily single-tablet antiretroviral regimen indicated as a complete treatment for HIV-1 in adults and children weighing at least 35 kg. Cimduo (lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg) is a once-daily combination of two nucleoside reverse transcriptase inhibitors that is indicated to be used in combination with other antiretroviral medications to treat HIV.
Mylan said that Symfi Lo’s efavirenz dose is one-third less than the dose originally approved in 1998, and the product was given tentative approval from the Food and Drug Administration in February under the U.S. President’s Emergency Plan for AIDS Relief program. The company dispensed the drug to more than 1 million patients worldwide last year, it said.
“Symfi Lo and Cimduo bring to the U.S. the innovations Mylan has pioneered in the delivery and dosage forms of ARVs used by millions of patients in high-burden countries around the world. We are proud of our continued investments in R&D and manufacturing for ARVs, and we are excited to extend the value of these to Americans living with HIV,” said Mylan President Rajiv Malik. “In particular, we believe the option to take a lower dose of efavirenz in a single-tablet regimen with Symfi Lo will be a welcome addition for patients and providers.”
The company said that it would discount Symfi Lo’s list price, and it would offer Cimduo as a significantly discounted list price compared with other similar treatments.
Amneal intros generic Tamiflu for oral suspension
Amneal Pharmaceuticals has introduced its generic Tamiflu for oral suspension (oseltamivir phosphate, 6 mg/ml). The Bridgewater, N.J.-based company’s product is a powder finished dosage that is packaged in bottles with 60 ml of usable volume following constitution.
Amneal’s generic Tamiflu for oral suspension joins generic Tamiflu capsules that it launched in July 2017.
“Approval and launch of this liquid form should be of great assistance to patients and caregivers,” Amneal executive vice president of commercial operations Andy Boyer said. “With a severe flu season upon us, our product should be able to help provide relief to thousands of patients. We are pleased to provide this liquid dosage form to patients, particularly the elderly and young who are unable to use an oral solid form.”
The drug is indicated to prevent the flu and as a treatment in patients who have been symptomatic for less than 48 hours. The drug’s market size was roughly $956 million for the 12 months ended December 2017, according to IQVIA data.
NACDS backs e-prescribing Senate bill
The National Association of Chain Drug Stores is backing legislation introduced in the Senate that would require electronic prescribing of controlled substances for Medicare Part D beneficiaries. The Every Prescription Conveyed Securely Act was introduced Tuesday by Sens. Michael Bennet, D-Colo., and Dean Heller, R-Nev., with Sens. Elizabeth Warren, D-Mass., and Pat Toomey, R-Pa., as co-sponsors.
“NACDS appreciates the leadership of Senators Bennet, Helller, Warren and Toomey in this important work to help confront the opioid-abuse epidemic,” NACDS President and CEO Steve Anderson said. “Electronic prescribing enhances security and curbs waste, fraud and abuse. This legislation is a vital aspect of a more comprehensive and effective approach to protecting families and communities.”
NACDS was one of ten associations and companies to send the senators a letter showing their support for the legislation. In the letter, the Arlington, Va.-based trade organization outlines the advantages of e-prescribing controlled substances, including the ease with which these prescriptions can be tracked and their resistance to forgery. E-prescribing of controlled substances has been a policy goal of NACDS’ and was included in its October letter that outlined its various policy stances to the President’s Commission on Combating Drug Addiction and the Opioid Crisis. NACDS said that its advocated policies are based on based on pharmacists’ experience on the front lines of healthcare, and are based on pharmacy’s longstanding collaboration with law enforcement and health professionals on the complex issue of opioid-abuse prevention.
In January, a Morning Consult poll commissioned by NACDS found that 76% of voters support a requirement to handle all prescriptions electronically as a way to combat the opioid epidemic.