Corporate News Blog - MannKind Announces Afrezza Updates from FDA; Includes New Data on Rapid Onset of Activity and Effect Duration
LONDON, UK / ACCESSWIRE / October 4, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for MannKind Corp. (NASDAQ: MNKD), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=MNKD. The Company announced on October 02, 2017, that the US Food and Drug Administration (FDA) has approved an update to the Afrezza prescribing information to include new clinical data. The Afrezza (human insulin) inhalation powder is now approved by the FDA to improve glycemic control in adult patients with type 1 and type 2 diabetes mellitus. Currently, it is the only inhaled rapid-acting mealtime insulin available in the United States, according to the Company. Afrezza is administered at the beginning of a meal and starts to appear in the blood in about one minute. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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About Afrezza
The Afrezza inhalation powder, which is available by prescription, is a rapid-acting inhaled insulin indicated to enhance glycemic control in adult patients with diabetes mellitus. It was studied in over 60 different clinical trials, evaluating over 3,000 people living with Diabetes type 1 and type 2. Afrezza is covered by different national and regional insurance plans whereby the Company offers a saving card that reduces the copay for most commercially insured patients to as little as $15. Afrezza is the only inhaled rapid-acting drug available today. The inhaled route of delivery spares patients from multiple mealtime injections and allows the patient to manage their disease in a different way.
Update Highlights
The inclusion of study data that describe the time-action profile by dosage strength, delivering first measurable effect in about 12 minutes, where peak effects occur about 35 to 45 minutes after dosing and return to baseline after about 1.5 to 3 hours for the 4- and 12-unit cartridges, respectively.
Clarity on ‘starting' and ‘adjusting' mealtime dose.
Updated pregnancy and lactation section to conform to current FDA label guidance.
These data, according to the University of Colorado, showcase the rapid-acting nature of Afrezza to address post-prandial hyperglycemia, differentiating it from other mealtime options available to help patients maintain greater control over their blood glucose levels.
The time for insulin effect of available cartridge forms is 12 minutes for both units, while the time to peak effect for the 4-cartridge unit is 35 minutes, and time for Afrezza 12-unit to achieve peak effect is 45 minutes. On the other hand, time for the effect to return to baseline is 90 minutes for the 4-cartridge unit and 180 minutes for 12-cartridge units.
The Company announced that it received a letter of Fulfillment of Post-Marketing Requirements, in conjunction with the approved labeling revision for PMR 2166-2 and PMR 2166-3, hence satisfying two of the four post-marketing requirements for Afrezza as mentioned in the 2014 FDA approval letter.
According to MannKind, available data suggests that about 70% of people living with diabetes on insulin are not at HbA1c goals of less than 7%. The Company firmly expects that in order for patients to achieve better HbA1c goals, control of mealtime glucose spikes is critical. This label update reinforces Afrezza as a unique fast-acting mealtime insulin that offers doctors and patients with the flexibility to help them achieve glycemic control.
Last Close Stock Review
On Tuesday, October 03, 2017, the stock closed the trading session at $2.82, surging 20.51% from its previous closing price of $2.34. A total volume of 12.85 million shares have exchanged hands, which was higher than the 3-month average volume of 2.73 million shares. MannKind's stock price skyrocketed 50.80% in the last one month, 127.42% in the past three months, and 101.43% in the previous six months. The stock is trading at a PE ratio of 2.09 and currently has a market cap of $302.02 million.
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