Apellis Pharmaceuticals Inc
NEWS
After identifying structural variations in the 19-gauge filter needle included in some eye injection kits, Apellis has advised doctors to only use 18-gauge kits already in circulation and that will be distributed.
Syfovre has been linked to rare cases of eye inflammation that could lead to blinding, though Apellis’ review so far has found no connection between the treatment and the complications.
The Massachusetts-based biopharma became the second company this week to drop its amyotrophic lateral sclerosis hopeful after it failed to elicit significant improvement compared with placebo.
The FDA has one target action date and one advisory committee meeting scheduled for this week. It is also gearing up for an adcomm that could prove to be pivotal for neurodegenerative diseases.
On Friday, the FDA approved Apellis Pharmaceuticals’ Syfovre (pegcetacoplan) as the first treatment for geographic atrophy (GA), a leading cause of blindness.
Apellis is submitting additional 24-month efficacy data to supplement the NDA for its intravitreal candidate pegcetacoplan for GA secondary to AMD.
Gene therapies developed by Janssen, Atsena, REGENXBIO and AbbVie showed promise against eye diseases this weekend at the American Academy of Ophthalmology 2022 meeting.
89bio presented positive data for pegozafermin in SHTG, Tonix enrolled its first patient with Long COVID for TNX-102, Belite enrolled patients with STGD1 and more clinical trial news.
FDA Weekly Review looks at the FDA’s actions related to drug approvals, IND approvals, designations and more. Here’s a look at what happened this week.
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