Getting FDA approval for novel drugs is a long and rigorous process. MerLion Pharmaceuticals, a biopharmaceutical company headquartered in Singapore with clinical development operations in Berlin, Germany, has announced that an otic (ear) suspension of finafloxacin, a fluoroquinolone antibiotic, has been approved by the FDA to treat acute otitis externa, commonly known as “swimmer’s ear”. MerLion claims this to be the first novel drug by a Singapore company to achieve FDA approval.
Swimmer’s ear is an infection in the outer ear canal, which runs from the eardrum to the outside of the head, caused by Pseudomonas aeruginosa and Staphylococcus aureus. It’s often brought on by water that remains in the ear after swimming, creating a moist environment that aids bacterial growth. The infection causes inflammation of the ear canal leading to pain, swelling, redness of the ear and discharge from the ear.
Mr. David Dally, CEO of MerLion, commented, “We are delighted to see that, following several years of the MerLion team working with our partner, the FDA has approved what we believe to be an excellent treatment for ear infections. This is especially pleasing since finafloxacin is the first novel drug from a Singapore company to achieve FDA approval.”
MerLion is a privately held company spun off by EDBI’s Bio*One Capital in 2002 from the former Centre for Natural Product Research (CNPR), originally a division of Singapore’s A*STAR (Agency for Science Technology and Research)’s Institute of Molecular and Cell Biology (IMCB). Along with EDBI, the company is supported by a group of leading global investors including Aravis Venture, Heidelberg Capital and Nomura Research & Advisory.
The full details of the drug approval is available here.