Glenmark Works to Address Concerns in FDA's CRL and Gain Approval for Ryaltris

FDA

Shares of Glenmark Pharmaceuticals are down more than 7% after the company announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for the company’s nasal spray Ryaltris being developed for the treatment of seasonal allergic rhinitis.

In a brief statement issued by the Mumbai, India-based company, Glenmark said the CRL cites “deficiencies in the Drug Master File pertaining to one of the active pharmaceutical ingredients and in the manufacturing facilities.” What the deficiencies are were not provided in the announcement. Glenmark did point out that the FDA’s CRL did not specify any deficiencies in the clinical data that was submitted to support the New Drug Application for Ryaltris (olopatadine hydrochloride and mometasone furoate).

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The news sent Glenmark’s shares falling to a year-low of 461 Indian Rupees, about $6.64 per share.

Glenmark said it will continue to seek regulatory approval for Ryaltris and will work closely with the FDA to determine the appropriate steps.

“We feel confident that we should be able to resolve these issues within the next six to nine months,” the company said in its announcement.

Ryaltris is an investigational fixed-dose combination antihistamine plus steroid nasal spray intended for the treatment of seasonal allergic rhinitis in patients 12 years of age and older. Ryaltris has been conditionally accepted by the FDA as the brand name and, if approved, is expected to bolster the company’s respiratory line, which includes GBR 310 (omalizumab), a proposed biosimilar candidate intended for the treatment of allergic asthma and chronic idiopathic urticarial.

If Ryaltris is ultimately approved by the FDA, the drug will be marketed in the United States by Glenmark Therapeutics Inc. USA, a subsidiary of the company. Earlier this year, Glenmark spun off its innovation business into a standalone company based in the United States. The new company launched with about 400 employees and has a focus on core areas of immunology, oncology and pain management. The new innovation business has its own chief executive officer and board of directors.

In addition to the CRL, Glenmark also announced this morning that it forged a relationship with Swiss pharma giant Novartis that will further strengthen its respiratory medications. Glenmark said its Brazilian subsidiary, Glenmark Farmacêutica Ltda, entered into the agreement for three respiratory products aimed at the treatment of chronic obstructive pulmonary disease. The medicines are intended to be marketed in Brazil. The products involved in the agreement are Seebri (Glycopyrronium bromide), Onbrize (Indacaterol) and Ultibro (combination of Indacaterol and Glycopyrronium), which are indicated for relief of symptoms in adults with COPD.

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