SIFI Announces the Grant of a Second FDA Orphan Drug Designation for Polihexanide in Fungal Keratitis
PR94953
CATANIA, Italy, Mar. 14, 2022 /PRNewswire=KYODO JBN/--
This follows the previously-granted ODD for polihexanide in Acanthamoeba
Keratitis by the FDA and EMA.
An estimated 15,660 patients with fungal keratitis are diagnosed annually in
the US.
SIFI S.p.A. ("SIFI" or the "Company"), a leading international ophthalmic
pharmaceutical company, announced today that the U.S. Food and Drug
Administration ("FDA") has approved the company's Orphan Drug Designation
("ODD") application for its investigational anti-infective polymer polihexanide
for the treatment of fungal keratitis. This is a second orphan ophthalmic
indication for the polihexanide Research & Development program.
Fungal keratitis is a severe corneal infection that often results in blindness
and eye loss. The disease is most prevalent in tropical and subtropical
climates. According to The Lancet (
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30448-5/fulltext
), annual global incidence of fungal keratitis is estimated at 1,051,787 cases,
with the highest rates in Asia and Latin America. In the U.S., an estimated
15,660 patients annually ¬– most of whom are contact lens wearers or
agricultural workers – are diagnosed with fungal keratitis. Only one drug is
currently approved for fungal keratitis in the U.S., and around one in three
patients fail on the treatment. There are no approved treatments for fungal
keratitis in Europe, Japan, Asia and almost anywhere else around the World. In
addition to lack of approved medical alternatives, the Company believes the
incidence of fungal keratitis may be on the uptick due the global trend in
general resistance to anti-fungal therapeutics.
"The opportunity of having a therapeutic option with new mode of action
available to treat patients with fungal keratitis is a breakthrough", says Dr
Edward Holland, Professor of Ophthalmology at the University of Cincinnati.
"Currently, we have limited topical options and therefore resort to surgery too
soon and often with the risk of poor outcomes as medical treatment proves
unsuccessful especially for deeper infections".
"Over the last year, we have accomplished several pivotal milestones towards
developing polihexanide first for acanthamoeba keratitis and now for fungal
keratitis," explained Maria-Grazia Mazzone, Executive Director of Business &
Portfolio Development at SIFI. “Both are catastrophic cornea infections with
dire consequences and, sadly, areas of unmet medical need. For the sake of the
patients we are encouraged by the recent decision of the FDA to grant ODD
status to this program, which will enable the efficient development and
ultimately approval of polihexanide for the treatment of fungal keratitis”,
concluded Mazzone.
The FDA's Orphan Drug Designation program provides orphan status to drugs that
are intended for the treatment, prevention, or diagnosis of a rare disease or
condition (affecting fewer than 200,000 persons in the U.S). Characteristics
of ODD status include seven years of post-approval marketing exclusivity,
federal tax credit for expenses incurred in conducting clinical research, and a
waiver of Prescription Drug User Fee Act ("PDUFA") fees.
SIFI is currently evaluating various options for the commercialization of
AKANTIOR(R) (polihexanide) globally, including potential out-license agreements
outside its core markets.
ABOUT polihexanide: It is an anti-infective polymer which acts via a dual
mechanism involving disruption of microorganism cell membranes and selective
condensation and/or disruption of microorganism chromosomes by DNA binding. In
addition to ODD for fungal keratitis granted by the FDA polihexanide has also
ODD for acanthamoeba keratitis granted by the FDA and the European Medicines
Agency ("EMA"). For acanthamoeba keratitis, polihexanide is formulated in a 0.8
mg/ml concentration and is being developed under the brand name AKANTIOR(R).
Following the announcement in October 2021, that AKANTIOR(R) met primary
endpoint in the phase III pivotal trial in acanthamoeba keratitis, SIFI plans
to file Marketing Authorisation Application ("MAA") at the EMA in Q2 2022. SIFI
will hold a 'Type B' meeting with the FDA for acanthamoeba keratitis in May
2022.
ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered
in Italy, focusing on eye care since 1935. SIFI develops, manufactures and
markets innovative therapeutic solutions for patients with ophthalmic
conditions. SIFI is fully committed through its R&D to improve the quality of
life of patients, exporting treatments to more than 20 countries worldwide with
a direct presence in Italy, Spain, France, Romania, Mexico and Turkey.
Reference:
Brown L., Leck AK, Gichangi M, Burton MJ, Denning DW, The global incidence and
diagnosis of fungal keratitis. The Lancet; Oct 2020
Key Contact:
Jelle Kleijn
Global Head of AKANTIOR(R)
+31-615643708
Jelle.kleijn@sifigroup.com
Sebastiano Giuffrida
Head of Clinical Development
+39-3357615356
sebastiano.giuffrida@sifigroup.com
Logo - https://mma.prnewswire.com/media/1337809/SIFI_Logo.jpg
Source: SIFI SpA
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