HORIZON LINES: A Quarterly Review of NDAs – April-June, 2018

This quarterly review on New Drug Applications (NDAs) contain data for applications approved for the first time during the second quarter of 2018, which includes New Molecular Entities (NMEs) and new biologics. A total of 33 applications were approved by the FDA during these three months.

The Advancing Hope Act of 2016 was signed into law on September 30, 2016, which amended the FD&C act. In this amendment, “pediatric disease” was defined as serious or life-threatening manifestations primarily affecting individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents.

FDA awards priority review voucher to sponsors of rare pediatric disease product applications, NDA or BLA. The sponsor can redeem this voucher to receive a priority review of a subsequent marketing application for a different product. On 13th June 2018, FDA granted Moxidectin approval to Medicines Development for Global Health (MDGH) for oral treatment of river blindness (onchocerciasis) in patients aged 12 years and older.

The FDA has also awarded MDGH a priority review voucher (PRV). Belcher Pharmaceuticals, LLC received approval for ABLYSINOL (dehydrated alcohol). It is a sterile, preservative free injectable solution of ≥99% by volume ethyl alcohol and no excipients. ABLYSINOL is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy.

Qbrexza is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older. It is the first-ever prescription treatment for excessive sweating.

Qbrexza contains 2.4% of glycopyrronium as an active ingredient, which is a competitive inhibitor of acetycholine receptor that are located on certain peripheral tissue, including sweat glands. In hyperhidrosis, glycopyrronium inhibits the action of acetycholine on sweat glands, reducing sweating.

Epidiolex (cannabidiol) oral solution is the first FDA-approved drug for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from cannabidiol, a chemical component of the Cannabis sativa plant, more commonly known as marijuana. Cannabidiol does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC), which is the primary psychoactive component of marijuana.

Fulvestrant is the only tentative approval made by FDA during this quarter. Final approval was not granted because of the unexpired exclusivity on the listed drug upon which the applicant relied and a waiver of that exclusivity which was not yet effective. To obtain final approval of this application, the applicant is expected to submit an amendment two or six months prior to the: 1) expiration of the patent(s) and/or exclusivity protection or 2) date applicant believes that their NDA will be eligible for final approval, as appropriate.

Following are the percentages of various NDA submission classifications in this quarter - 30% Type 1 (new molecular entity), 2.7% Type 2 (new active ingredient – ester, salt etc.), 13.5% Type 3 (new dosage form), 13.5% Type 4 (new combination), 24% Type 5 (new formulation or other differences – new indication, new applicant or new manufacturer), 2.7% Type 10 (new indication or claim) and 13.5% BLA.

HORIZON LINES: A Quarterly Review of NDAs – April-June, 2018


HORIZON LINES: A Quarterly Review of NDAs – April-June, 2018
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