FDA spurns hay fever drug from India's Glenmark
In its attempt to be transparent about manufacturing machinery, Indian drugmaker Glenmark appears to have shot itself in the foot with the FDA. On Saturday, the Maharashtra-based company disclosed that its hay fever drug, Ryaltris, had been rejected by the US health regulator.
In its complete response letter, the FDA cited deficiencies in the Drug Master File (DMF) related to one of the active pharmaceutical ingredients and a manufacturing plant, Glenmark noted in a statement, adding that it is confident the issue can be resolved in the next 6 to 9 months.
The DMF — which encompasses confidential detailed information about the manufacturing, processing, packaging, and storing of human drugs — is not obligatory under law or FDA regulation, and it’s submitted solely under the discretion of the manufacturer, according to the agency.
Ryaltris is a fixed dose nasal spray formulation of an antihistamine and a steroid (olopatadine hydrochloride and mometasone furoate) — and was submitted for approval on the basis of twin, positive pivotal studies. Altogether, the studies enrolled 2,352 patients aged 12 and over and showed Ryaltris conferred a statistically significant improvement in symptoms versus a placebo. The FDA’s rejection is unrelated to Ryaltris’ clinical data, Glenmark said.
Although India — sometimes referred to the pharmacy of the world — is the primary manufacturer and exporter of generic treatments to the United States, the record of quality control in Indian manufacturing facilities has at times been poor, sparking regulatory ire and a raft of recalls. Recent reports have also suggested that the FDA has reduced its surveillance activities in the region — leaning heavier on its European counterparts — although the number of warning letters to manufacturers have gone up.
So far, Glenmark is probably the only Indian company to not have received any warning letters from the FDA, a Glenmark spokesperson told Endpoints News.
“We are not aware of any quality issue on the API cited in the CRL” the spokesperson said, noting that the ingredient is manufactured by a third party and that the FDA decision will have no material impact on Glenmark’s global revenue.
On Monday, Glenmark notched an agreement with Novartis $NVS to sell three respiratory drugs in Brazil. Back in March, the largely generic drugmaker unveiled that Gilead $GILD executive (and Novartis vet) Alessandro Riva will head up its new US-based biotech spinoff from Glenmark, focused on oncology and T cells.