Octapharma gets FDA approval for new product strengths of NUWIQ
HOBOKEN, N.J. — Octapharma USA today announced that the U.S. Food and Drug Administration has approved new product strengths for NUWIQ. The move potentially reduces the number of vials needed for hemophilia A patients, the company said.
The agency approved new-single dose vial strengths of 2500-, 3000- and 4000-IU, which will be available for ordering in the United States starting Sept. 2017. These new vial strengths will be provided in addition to the already available strengths of 250-, 500-, 1000- and 2000 IU. NUWIQ is the only recombinant Factor VIII providing patients a wide array of vials with the lowest diluent volume of 2.5ml, the company added.
NUWIQ anti-hemophilic factor (recombinant) lyophilized powder for solution for intravenous injection is a recombinant anti-hemophilic factor indicated in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes; perioperative management of bleeding; and routine prophylaxis to reduce the frequency of bleeding episodes.
“The new vial options will benefit patients, physicians and healthcare professionals by providing greater treatment flexibility and convenience,” said Flemming Nielsen, Octapharma USA president. “The variety of vial options will be particularly beneficial to patients who previously may have needed more than one of the lower-strength vials. The availability of the new vial strengths further illustrates Octapharma’s unwavering commitment to the Hemophilia A community.”
The additional vial strengths offer benefits beyond potentially reducing the number of vials used per patient. The new vial sizes may benefit heavier patients who could use fewer product vials and, in some cases, just one vial, according to the company. More NUWIQ vial options will increase dosing flexibility by allowing physicians to select various vial combinations to align closer to the prescribed dose. The new vial sizes could be particularly beneficial to patients treated with NUWIQ utilizing a pharmacokinetic-guided personalized prophylaxis approach — wherein the dosing is further optimized compared with standard prophylaxis.
Amneal launches generic form of Tamiflu
BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched oseltamivir phosphate capsules, USP, in three strengths: 30-mg, 45-mg and 75-mg. The Amneal generic is an AB-rated therapeutic equivalent to Tamiflu. Each strength is available in 10-count blister dose-packs.
“Flu season is closer than we realize,” said Jim Luce, Amneal EVP, sales and marketing. “Amneal strives to assist healthcare providers and their patients by providing more affordable and greater access to treatment with our generic medication.”
Manufactured in the recently expanded Amneal facility in Brookhaven, N.Y., oseltamivir capsules began shipping July 11 from the company’s Glasgow, Ky., distribution center and can be purchased through major wholesalers and distributors. Annual U.S. sales of Tamiflu were $444 million according to May 2017 QuintilesIMS market data.
As generics savings increase, FDA looks to spark competition
Generic medications made up 89% of dispensed U.S. prescriptions in 2016, but only 26% of total drug costs. The use of generics brought savings of $253 billion in 2016, bringing the 10-year savings from generics to $1.67 trillion, according to the ninth annual “Generic Access and Savings in the U.S.” report compiled by the QuintilesIMS Institute for the Association for Accessible Medicines (formerly the Generic Pharmaceutical Association).
The savings report, published in June, highlighted the importance competition in the generics market plays in driving down costs — something the Food and Drug Administration has taken an interest in this year with its Drug Competition Action Plan, informed largely by the savings that generics bring.
AAM’s report highlighted that Medicare saved roughly $1,883 per enrollee ($77 billion) and Medicaid saved $512 per enrollee ($37.9 billion) as a result of using generics. The therapeutic categories that saw the most savings were mental health, with $44 billion in savings; hypertension, which saw $29 billion in savings; and cholesterol, which saw $28 billion in savings.
The savings that generics and biosimilars bring, AAM reported, act as a driver for access to treatment for patients.
“Access is a value we uphold at every opportunity,” AAM president and CEO Chip Davis said when the report was released. “All of our work, from promoting marketplace competition to advocating strategic enhancement of the Food and Drug Administration’s generic drug and biosimilar approval process, comes down to the promise of putting treatments within the reach of patients.”
The report also includes data from researchers who looked into abandonment behaviors of patients with regard to both branded and generic products, finding that new patients abandon branded drugs at a rate 266% higher than they do generic drugs. The report noted that co-pays play a key role in abandonment, with 14% of patients who abandon a branded medication switching to a generic within 30 days of initial approval.
The FDA’s new commissioner, Dr. Scott Gottlieb, has not required much convincing as to the value of increased generics usage. In July, Gottlieb unveiled his plan to increase competition among generics manufacturers in an effort to drive costs down.
Gottlieb’s first move was to have the FDA release a list of branded drugs that have no listed patents or exclusivities with no currently approved generics. The agency also instituted a new policy to speed up review of applications for generic versions of products with limited competition. Additionally, the FDA has promised to expedite review of any generic application for a product on the list to speed up its time to market. And more broadly, the agency said that it would begin expediting the review of applications until there are three generics for a given product.
“No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require,” Gottlieb said. “Getting safe and effective generic products to market in an efficient way, being risk-based in our own work and making sure our rules aren’t used to create obstacles to new competition can all help make sure that patients have access to more lower-cost options.”
Preventing drug makers from using FDA tools to limit competition is another crucial element of the Drug Competition Action Plan. One difficulty that generics companies run into is getting access to branded products for comparative testing, which the FDA said some manufacturers attempt to limit.
Gottlieb has pointed specifically to the difficulty some companies have in accessing medications under limited distribution — either voluntarily or through a Risk Evaluation and Mitigation Strategy. Additional, potentially limiting efforts include using the legal requirement to have a single, shared REMS across branded and generic versions of a drug as a way to block generic entry, as well as prolonging negotiations with generics makers over the single, shared system, Gottlieb said.
In addition to efforts to identify places to rein in drug makers, the FDA also is focusing on clearing out its backlog of applications for approval. At a July 18 public meeting, at which the FDA called for public comment, Gottlieb said that it marked the beginning of a new internal strategy for dealing with abbreviated new drug applications, as well as the starting point for a guidance on the best submission practices for drug makers.
Before the end of 2017, the FDA said it would issue a Manual of Policies and Procedures pertaining to internal policies that will streamline the review process, and that it would share a “Good ANDA Submission Practices Guidance” guidebook for manufacturers.
“Neither our internal MAPP nor the guidance alone can ensure that ANDAs will be approved more efficiently,” he said. “But taken together, I believe they will help effectuate real and measurable change.”