FDA OKs first generic under new approval pathway
The Food and Drug Administration today approved several strengths of potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy designation.
This new approval pathway was created to expedite the development and review of a generic drug for products that lack competition.
Potassium chloride is an oral treatment that is indicated for the treatment and prevention of hypokalemia (low potassium blood levels) in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible.
The FDA gave the nod for Apotex’s potassium chloride oral solution.
“Today’s approval marks the successful implementation of a new program designed to encourage generic drug development for products with inadequate generic competition,” said FDA commissioner Scott Gottlieb, in a press statement.
“The quick implementation of this new pathway is part of our broader effort to foster generic competition and help address the high cost of drugs. So are our efforts to narrow the time it takes for generic drugs to reach the market by reducing the number of review cycles that generic applications typically undergo. This new generic drug application was also approved in its first cycle of review. This approval demonstrates that the competitive generic therapy pathway is efficient and open for business. This pathway is a key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need,” said Gottlieb.
Under new authorities provided to the agency in the FDA Reauthorization Act of 2017 (FDARA), a drug can be designated as a Competitive Generic Therapy if there is inadequate generic competition for that drug, meaning there is not more than one approved drug in the active section of the Orange Book.
The potassium chloride oral solution products approved (potassium chloride oral solution USP, 10% (20 mEq/15 mL) and 20% (40 mEq/15 mL)) are eligible for 180 days of CGT exclusivity.
Report: Genoa Healthcare may be for sale
Private-equity firm Advent International has reportedly held talks with potential buyers about the sale of pharmacy company Genoa Healthcare, according to a Bloomberg report.
Walgreens Boots Alliance is said to be among those suitors interested in Genoa, Bloomberg’s report said.
Genoa, which is estimated to be worth about $2.5 billion has more than 400 full-service pharmacies within community mental-health centers. It serves about 650,000 customers and has more than 250 psychiatrists and nurse practitioners who provide telepsychiatry services to mental-health patients, according to the report.
A Walgreens deal with Genoa would add to Walgreens’ number of pharmacies, which increased last year when the chain acquired 1,932 new stores from Rite Aid.
Allergan, Editas Medicine to develop genomic medicines to treat eye diseases
Allergan and Editas Medicine, a leading genome editing company, have joined forces to develop and commercialize EDIT-101 globally for the treatment of Leber Congenital Amaurosis, or LCA, a group of inherited retinal degenerative disorders caused by mutations in at least 18 different genes.
LCA is the most common cause of inherited childhood blindness, with an incidence of two to three per 100,000 live births worldwide. Symptoms of LCA appear within the first years of life, resulting in significant vision loss and potentially blindness. The most common form of the disease, LCA10, is a monogenic disorder caused by mutations in the CEP290 gene and is the cause of disease in approximately 20%-30% of all LCA patients.
CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a tool that can be programmed to target specific stretches of genetic code and edit DNA at precise locations in the human genome. The technology allows researchers to permanently modify genes.
“CRISPR-based medicines have the potential to be game-changers for patients with both genetically-defined and genetically-treatable diseases of the eye,” Allergan chief research and development officer David Nicholson said, in a statement.”The Allergan team is excited to work with colleagues at Editas Medicine to develop EDIT-101 and potentially deliver a transformative medicine for LCA10 patients.”
“Today marks a significant milestone in our collaboration with Allergan and in our work to develop genomic medicines to treat eye diseases,” Editas Medicine president and CEO Katrine Bosley said, in a statement. “Allergan is a long-time innovator in ophthalmology, and their deep experience in developing, manufacturing, and commercializing medicines globally will meaningfully advance the EDIT-101 program and maximize our ability to bring this transformative medicine to people living with LCA10.”