Mylan Given Rights to Market TOBI Solution and TOBI Podhaler in UK

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by Joana Carvalho |

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The European Commission (EC) and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) granted Mylan the right to market TOBI Podhaler (tobramycin inhalation powder) and TOBI Solution (tobramycin nebulizer solution) in the United Kingdom, the company announced.

The decision came after the Committee on Human Medicinal Products (CHMP) issued a positive recommendation for the transfer of marketing authorization rights.

Tobramycin is an inhaled antibiotic used to treat chronic lung infections caused by Pseudomonas aeruginosa in adults and children, ages six or older, with cystic fibrosis (CF). Repeat bacterial infections damage the lungs, leading to scarring (fibrosis) and raising a risk of respiratory failure.

The medicine is currently commercialized as a nebulizer solution, sold under the brand name TOBI Solution (300 mg/5 ml for nebulisation), or as dry powder capsules and sold under the brand name TOBI Podhaler (28 mg per capsule). Both medications require the use of a specialized inhaler to be administered properly.

TOBI Solution and TOBI Podhaler were developed and first commercialized by Novartis, but Mylan closed an agreement with that company for worldwide rights to market both products in 2018.

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The recommended dose for TOBI Solution is one ampoule twice a day for 28 days, whereas for TOBI Podhaler is 112 mg of tobramycin (four capsules of 28 mg) twice daily for 28 days. Both medications must be taken in alternating cycles of 28 days of treatment, followed by 28 days of non-treatment. More information about dosing, scheduling, and possible side effects are listed in the full prescribing information for TOBI Solution and TOBI Podhaler.

Mylan welcomed the decision by European regulatory authorities, saying it represents the company’s continuing commitment to CF patients and life quality. About 10,500 people in the U.K. are living with CF, a medical condition that requires rigorous treatment and follow-up.

“We’re very pleased that Mylan becomes the marketing authorisation holder for TOBI Podhaler and TOBI Solution,” Jose Cotarelo, Mylan area director for Northern Europe, said in a press release. “Mylan have continually supported the cystic fibrosis community and as treatments improve, patients are living longer. It is imperative therefore, that we continue to develop care regimes that improve patients’ quality of life.”


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