Novartis reiterates its faith in Eylea rival Beovu; Anti-NGF drug from Lilly, Pfizer is accepted for FDA review
→ Last month, the Chicago-based American Society of Retina Specialists highlighted 14 cases of retinal vasculitis that have recently emerged with Regeneron’s Eylea rival — Novartis’ Beovu. Analysts also identified 36 serious cases reported to the FDA Adverse Event Reporting System, with 2 cases of vasculitis, 6 cases of blindness and 4 cases of eye inflammation. Novartis, which has previously said it had engaged an external safety review committee to look into these post-marketing safety concerns, issued a press release on Monday backing the drug, saying it believes the incidence of these events is consistent with the medicine’s package insert.
In contrast to Beovu, there were no recorded cases of retinal vasculitis in late-stage trials of Eylea. In pivotal studies of the Novartis therapy, intraocular inflammation and blindness were reported in 4% and 1% of patients, respectively. “Novartis stands behind the safety and efficacy of Beovu when used as indicated,” the company reiterated.
An FDA spokesperson on Monday told Endpoints News that it “takes reports of adverse events very seriously and we are looking into the issue.”
→ About a decade ago, drugs designed to target nerve growth factors (NGF) to manage chronic pain were abandoned after significant safety concerns cropped up in trials. But some drug developers, in consultation with the FDA, soldiered on in a bid to carve a safer path forward for this family of compounds. Pfizer and Eli Lilly think their anti-NGF — tanezumab — fits the bill, with the two partners hoping they can squeeze past the FDA with the low-dose version of the therapy. On Monday, Lilly disclosed the FDA had accepted for review the marketing application for tanezumab 2.5 mg for patients with chronic pain due to osteoarthritis.
→ Three years after it first paid fines for its role in the US opioid abuse epidemic, Mallinckrodt last week agreed-in-principle to shell out $1.6 billion and place its generics unit in bankruptcy. On Monday, the embattled UK-based drugmaker said it had initiated a rolling marketing application with the FDA for its kidney drug, terlipressin. Pivotal data in patients with a life-threatening, progressive rare complication of liver disease that triggers kidney failure called hepatorenal syndrome type 1 (HRS-1), which affects an estimated 30,000 to 40,000 in the United States each year, was published in August.
→ Immuno-oncology company Marker Therapeutics has entered into a deal where Chicago-based institutional investor and long-term shareholder Aspire Capital Fund will buy up to $30 million of its stock.