Mannkind vor Explosion?

So, da hat Mannkind nun wohl eine zweite Substanz in der Mache.

Irgendwie haben die Verantwortlichen bei Mannkind ein Talent, sich mit ihrem Therapieangebot Erkrankungen auszusuchen die nicht so recht passen.

Eine Inhalation, als Applikationsweg eines Medikamentes, bei Pulmonaler Hypertonie anbieten zu wollen ist schon sehr optimistisch.

Eines der größten Probleme dieser Patienten ist die Dispnoe (Atemnot), also Kurzatmigkeit.
Dies betrifft 60-100% der Patienten, je nach Stadium der Erkrankung.

Es gibt hier zwei große Gruppen (von 5 WHO Einteilungen) bei der PH
(1.) pulmonal arteriellen Hypertonie und PH aufgrund Linksherzerkrankung.
(2.) chronisch obstruktive und fibrosierende Lungenerkrankungen die zu einer PH führt.

Wie man bei solch einem Klientel eine Therapie in Erwägung zieht, die auf eine gute Resorption des Wirkstoffes über die Atemwege angewiesen ist, kann ich nicht nachvollziehen.

Nun, warten wir´s mal ab.

Wen das Thema interessiert......
flexikon.doccheck.com/de/Pulmonale_Hypertonie#WHO-Einteilung

www.aerzteblatt.de/archiv/186048/Pulmonale-Hypertonie

flexikon.doccheck.com/de/...mboembolische_pulmonale_Hypertonie

Riesenschritt in Richtung bessere Vermarktung, bessere Versicherungsabdeckung, bessere Ärzteüberzeugung, Verpartnerung ........ die Kinderstudie ist viel einfacher..... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 022472/S-017 SUPPLEMENT APPROVAL MannKind Corporation Attention: Robyn Walsh, M.S. Senior Manager, Regulatory Affairs One Casper Street Danbury, CT 06810 Dear Ms. Walsh: Please refer to your supplemental New Drug Application (sNDA) dated and received April 19, 2018, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Afrezza (insulin human) inhalation powder. This Prior Approval sNDA provides for proposed modifications to the approved Afrezza risk evaluation and mitigation strategy (REMS). This supplement is in response to our April 17, 2018, REMS Modification Notification letter. We have completed our review of this supplemental application. It is approved effective on the date of this letter. RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS The REMS for Afrezza (insulin human) inhalation powder was originally approved on June 27, 2014, and the most recent REMS modification was approved on April 20, 2015. The REMS consists of a communication plan and a timetable for submission of assessments of the REMS. In order to minimize burden on the healthcare delivery system of complying with the REMS, we determined that you were required to make the REMS modifications outlined in our REMS Modification Notification letter dated April 17, 2018. Communication Plan: We have determined that the communication plan is no longer necessary as an element of the REMS to ensure the benefits of Afrezza (insulin human) inhalation powder outweigh its risks because the communication plan has been completed and the most recent assessment demonstrated that the communication plan has met its goals. No further assessments are necessary to assess the current communication plan. Therefore, because the communication plan is no longer necessary to ensure the benefits of the drug outweigh the risks, a REMS is no longer required for Afrezza (insulin human) inhalation powder. Reference ID: 4252859 NDA 022472/S-017 Page 2 REQUIRED PEDIATRIC ASSESSMENTS Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients (which includes new salts and new fixed combinations), new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable. Because none of these criteria apply to your supplemental application, you are exempt from this requirement. REPORTING REQUIREMENTS We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80 and 314.81). If you have any questions, call Michael G. White, Ph.D., Regulatory Project Manager, at (240) 402-6149. Sincerely, {See appended electronic signature page} Jennifer Rodriguez Pippins, M.D., M.P.H. Deputy Director for Safety Division of Metabolism and Endocrinology Products Office of Drug Evaluation II Center for Drug Evaluation and Research

Das kann der langersehnte Turnaround werden!

“We are excited to share the progress of the ongoing pediatric study program,” said David Kendall, M.D., Chief Medical Officer of MannKind. “As is well known, type 1 diabetes is often diagnosed in children and adolescents, and these individuals will continue to require insulin therapy throughout their lives. Evaluating as quickly as possible the potential use of Afrezza in children and adolescents as an option for mealtime insulin therapy is a top priority for MannKind.”

Poster 136-LB:   Effective Treatment of T2D Patients Uncontrolled on Multiple Diabetes Medications by Adding Afrezza® Mealtime Ultra-Rapid Insulin

Dr. Philip Levin and colleagues presented data from an independent study supported and funded by MannKind. Dr. Levin presented late-breaking clinical data on interim results of a study² showing how a fixed titration schedule can be implemented to achieve better time in range and reduction of overall A1c.

Late Breaking Poster Highlights:

   Enrolled adult patients with uncontrolled type 2 diabetes on two or more therapies (orals/ basal/ GLPs) – with the addition of Afrezza at all meals by means of a rapid and ongoing titration protocol
   Observed a mean decrease in A1c of ~1.6% (all subjects with A1c reduction over 12 weeks of study)
   93% (13 of 14 subjects) achieved A1c below 8% (mean baseline A1c 9.1%)
   Reduced hyperglycemia (>250mg/dL) by 74%
   Increased time in range more than 75%; daily glucose decreased by ~50 mg/dL as measured by blinded continuous glucose monitoring
   No significant difference in rates of hypoglycemia with the addition of Afrezza

“We are pleased to share the interim analysis from our independent investigator-initiated trial of Afrezza therapy. These preliminary data significantly advance our understanding of the potential clinical benefits and practical use of Afrezza therapy for those living with type 2 diabetes,” stated Philip Levin, M.D. of Bay West Endocrinology Associates and MODEL Clinical Research in Baltimore, MD. “Data generated to this point are encouraging and support the use of Afrezza as prandial therapy earlier in the treatment of type 2 diabetes.”

Oral Abstract
151-OR: Technosphere Insulin Provides Better Early Postprandial Glucose Control than Subcutaneous Rapid-Acting Analog

MannKind investigators also shared data at an oral presentation³ using mixed meal tolerance testing to assess glucose control, Afrezza dosing and overall safety in a cohort of individuals with type 1 diabetes.

Oral Presentation Highlights:

   When compared to rapid acting injected insulin, Afrezza provided significantly better glucose control in the first two hours following the meal.
   Even when adjusting the dose of Afrezza using up to two times the dose of injected insulin aspart, Afrezza treatment was associated with lower rates of overall and level 2 hypoglycemia - an observation that was particularly evident in the late (>2 hour) post-meal period.

Dr. Anne Peters, Clinical Professor of Medicine at the Keck School of Medicine at USC and Director of the USC Westside Center for Diabetes Care noted that “the improved post-meal glucose levels and lower rates of low blood sugars seen in this study of individuals with type 1 diabetes support my growing clinical experience. The presentation of these data provides further evidence that proper dosing of Afrezza has the potential to safely and effectively get more patients into target range at meal times.”

About Afrezza®

Available by prescription, Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus.  Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within minutes of administration.  Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels.  For Afrezza doses exceeding 12 units, patients ma