Afrezza could breathe new life into inhaled insulin market
pharmafile | August 15, 2011 | News story | Research and Development, Sales and Marketing | diabetes, inhaled insulin, insulin, research and development news
New trials for MannKind’s investigational inhaled insulin drug Afrezza have been given the go-ahead by the FDA, potentially breathing new life into the market.
The US regulator has cleared MannKind’s design for two clinical studies to evaluate the efficacy and safety of Afrezza (insulin human [rDNA origin]), an ultra rapid-acting mealtime insulin therapy, administered using MannKind’s next-generation inhaler.
MannKind’s initial license application for Afrezza was turned down by the FDA, which said in January that additional clinical trials would need to be conducted before it would look again at approving the new treatment.
These trials will include a treatment group using the previously studied MedTone inhaler, in order to obtain a head-to-head comparison of the pulmonary safety data for the two devices.
Inhaled insulin was once seen as the Holy Grail for pharma, but has met with much difficulty.
Pfizer’s Exubera was the first such treatment to reach the market, but was later withdrawn in mid-2007 after it failed to catch on with doctors.
Lilly’s AIR insulin product suffered a similar setback in 2008 when it cancelled phase III trials of its drug due to the “increasing uncertainties in the regulatory environment,” which looked to be the end of inhaled insulin.
MannKind has however remained dedicated to producing an inhaled insulin product, and even acquired Pfizer’s Exubera manufacturing facility, and said it remains confident Afrezza will make it to market.
Hakan Edstrom, president of MannKind, said: “We held a successful meeting with the FDA yesterday, confirming the protocols for the type I and type II studies.
“We were also encouraged to proceed promptly with the initiation of both clinical trials,” he added.
Afrezza study design
The first trial – study 171 – will be an open-label study in type I diabetics. After a run-in period, during which all patients will be optimised on their basal insulin regimen, patients will be randomised to one of three arms.
These include a control arm, in which patients use an injected rapid-acting insulin at mealtimes, or one of two Afrezza arms, one each for the MedTone and next-generation device.
There will then be a 12-week observation period on stable doses of the mealtime insulin to assess sugar levels (HbA1c), the primary outcome for the trial.
Study 174 will assess Afrezza using the next-generation inhaler in patients with type II diabetes that are inadequately controlled on the oral antidiabetic metformin with or without a second or third oral medication.
Patients will be randomised to treatment with the drug or placebo and, as with the first study, will be followed by a 12-week observation period to assess HbA1c levels.
Afrezza is a drug-device combination product, consisting of its own inhalation powder pre-metered into single use dose cartridges with the inhaler.
The drug is administered at the start of a meal and is designed to dissolve upon inhalation to deliver insulin quickly to the blood stream.
Peak insulin levels are achieved within 12 to 14 minutes of administration, mimicking the release of mealtime insulin observed in healthy individuals.
Ben Adams
Related Content
CHMP recommends Novo Nordisk’s Awiqli for diabetes treatment
Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for …
Roche shares data on novel solution for continuous glucose monitoring
Roche has shared the latest data on its novel solution for continuous glucose monitoring (CGM), …
Novo Nordisk shares positive results from COMBINE 3 phase 3a trial
Novo Nordisk has shared topline results from the COMBINE 3 phase 3a trial of once-weeklly …
