A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Mylan, Biocon, Roche, GlaxoSmithKline, and Takeda.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, January 24, 2017 to Tuesday, January 30, 2017.

EMA Advisory Committee Recommends Mylan’s, Biocon’s Biosimilar of Sanofi’s Lantus
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a biosimilar to Sanofi’s diabetes drug Lantus (insulin glargine) from Mylan and Biocon, a Bangalore, India-based pharmaceutical company, called Semglee (insulin glargine). Lantus had 2016 sales of EUR 5.71 billion ($6.54 billion).

Semglee is a long-acting insulin analog used in treating diabetes mellitus in adults, adolescents, and children aged two years and above.

The CHMP positive opinion will be considered by the European Commission. The European Commission decision on the approval is expected in April 2018.

In addition to the European submission, marketing applications for Semglee have been submitted in Australia, Canada, and the US and are planned for emerging markets.

Source: Mylan and Biocon 

EMA Advisory Committee Recommends Roche’s Hemophilia Drug Hemlibra
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Roche’s Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in people in all age groups with hemophilia A with factor VIII inhibitors.

The Hemlibra marketing authorization application is being reviewed under accelerated assessment, a procedure granted to medicines that the CHMP believes are of major interest for public health and therapeutic innovation.

Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins required to activate the natural coagulation cascade and restore the blood clotting process for people with hemophilia A.

Source: Roche

EMA Advisory Committee Recommends GSK’s Shingles Drug Shingrix
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for GlaxoSmithKline’s Shingrix, a vaccine for preventing shingles (herpes zoster) and post-herpetic neuralgia, a common shingles-related complication, in adults aged 50 years or older.

Shingrix is a non-live, recombinant subunit adjuvanted vaccine given intramuscularly in two doses, with a two-to-six month interval between doses.

A final decision by the European Commission is anticipated in April 2018.

Shingrix was approved in Canada and the US in October 2017 and has been recommended by the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices for preventing herpes zoster and related complications for immunocompetent adults aged 50 years and older. Regulatory reviews of the vaccine are currently underway in Australia and Japan.

Source: GlaxoSmithKline

FDA Accepts Mylan’s, Theravance Biopharma’s NDA for COPD Drug
The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) from Mylan and Theravance Biopharma, a South San Francisco, California-headquartered biopharmaceutical company, for revefenacin, an investigational long-acting muscarinic antagonist, for treating chronic obstructive pulmonary disease (COPD).

If approved, revefenacin would be the first once-daily, nebulized bronchodilator for treating COPD, according to the companies. The FDA has assigned a Prescription Drug User Fee Act target action date of November 13, 2018, and indicated that it does not currently plan to convene an advisory committee meeting to discuss the NDA.

Source: Mylan and Theravance Biopharma

FDA Grants Fast-Track Designation for Takeda’s Zika Vaccine Candidate
The US Food and Drug Administration (FDA) has granted Takeda Pharmaceutical Company fast-track designation for TAK-426, Takeda’s purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate.

The FDA’s fast-track designation is a process designed to facilitate the development and expedite the review of drugs and vaccines for medical conditions and that fill an unmet medical need. The fast-track process allows more frequent interactions with the FDA, rolling reviews of the biologic license application, and eligibility for a priority review if relevant criteria are met.

Takeda’s Zika vaccine candidate is currently being studied in a Phase I trial under a US investigational new drug application. Beyond Zika, Takeda is pursuing several vaccine programs to address infectious diseases, including dengue, norovirus, and polio. Takeda’s dengue vaccine candidate, TAK-003, was also granted fast-track designation and is being evaluated in a Phase III efficacy study, with initial data expected in 2018.

Source: Takeda Pharmaceutical Company