Lannett, Lanexa Biologics and Sunshine Lake secure FDA approval for Langlara

Langlara is cleared for use in adults and children with type 1 diabetes mellitus (T1DM), as well as adults with type 2 diabetes mellitus (T2DM).

The FDA’s decision enables pharmacists in eligible states to substitute Langlara for Lantus without needing approval from the prescriber.

The approval follows a preclinical, comprehensive analytical, and clinical programme that confirmed Langlara’s pharmacokinetics, pharmacodynamics, efficacy, safety profile, and immunogenicity were consistent with Lantus among patients with T1D and T2D.

Langlara is manufactured by Sunshine Lake Pharma, part of the HEC Group and commercialised in the US via Lanexa Biologics.

Sunshine Lake Pharma’s facility complies with regulatory standards required in the US and other international markets. The two companies are also working together on developing a short-acting insulin aspart.

Lannett CEO Tim Crew said: “Upon the launch of Langlara, supported by the tremendous manufacturing scale of our partner, patients will have expanded access to a safe, affordable and available treatment option. In fact, the scale required to support this medicine is the very reason so few insulin manufacturers exist.

“Moreover, earning the interchangeability designation is critical for patient access and reflects the extraordinary quality and scientific rigour of both Lannett and our partner Sunshine Lake Pharma. Lannett and Lanexa Biologics intend to pursue broad formulary placement across all commercial channels, to make this medicine accessible for all who need it.”

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