VALENCIA, Calif. ( TheStreet) --Some of the statements by MannKind ( MNKD) today regarding the FDA's complete response letter for its inhaled insulin device Afrezza aren't entirely clear. Let's hope the company clarifies matters Tuesday when executives hold a conference call.
  • In its statement, MannKind says FDA asked for "information and currently available clinical data that support the clinical utility of Afrezza." emphasis added.

    What does "clinical utility" mean? Is the FDA questioning the clinical need for an inhaled insulin device to treat diabetics, and therefore wants MannKind to justify Afrezza's utility?

    Such a request by FDA isn't a particularly optimistic sign for Afrezza's eventual approval. The agency commonly questions the efficacy and safety of a medical device or drug, but I'm not sure I can recall a situation where FDA wants a company to defend the need or utility for a device or drug. Perhaps this is a semantics question, but it's one that MannKind should clear up Tuesday.
  • According to MannKind, the FDAs complete response letter "did not require any additional pre-marketing clinical studies in order for the FDA to complete its review of the NDA." Emphasis added.

    The FDA not asking for new clinical trials as a pre-condition for approval is usually a good thing, but is that what Mannkind is really saying here? The company's statement says FDA didn't ask for new trials to "complete" its Afrezza review, but is that the same thing as saying FDA didn't ask for new trials in order to approve the device?

    Again, this might be picking semantic nits, but check out how Cadence Pharmaceuticals ( CADX) described on Feb. 11 the FDA complete response letter received for its experimental intravenous acetaminophen: "The FDA did not cite any safety or efficacy issues, nor did it request any additional studies to be conducted prior to approval."

    Definitely different wording. Different meaning?
  • In January, MannKind said that the FDA was forced to delay its Afrezza review because the agency had not completed an inspection of a third-party manufacturing plant in Europe that makes the insulin used in the device.

    Yet Monday, MannKind's statement says nothing about the status of this inspection holdup.
  • Mannkind says it plans to schedule a meeting with FDA to review the Complete Response Letter. The company doesn't say when that meeting will take place, nor does the company offer any specific timelines about resubmitting requested information to the FDA.

    Even under generous assumptions, it doesn't seem like FDA could be in a position to approve Afrezza before 2011. MannKind, on its call tomorrow, should provide an updated regulatory timelines, even a rough guess, given that the expectations are for Afrezza to be approved this year.

FDA Delays MannKind Diabetes Approval

(Updated at 10:04 AM EDT)

U.S. regulators have delayed the approval of an inhaled insulin drug and device from MannKind Corp. ( MNKD), the company said Monday.

The U.S. Food and Drug Administration asked MannKind to provide updated data on the safety and efficacy of its Afrezza device and additional information about the inhaler used to deliver the insulin to the lungs. The FDA, however, did not ask for new clinical trials, MannKind said in a statement.

MannKind shares fell 7% to $9.71 in early Monday trading.

The announcement of FDA's complete response letter for Afrezza comes two months past its original Jan. 16 approval decision deadline. In early January, MannKind said FDA requested more time for the Afrezza review, in part, to complete inspection of a European manufacturing facility that makes the device's insulin.

MannKind's statement Monday does not mention whether that inspection was completed.

"We are currently reviewing the Complete Response letter and fully expect that we will be able to respond to the FDA's requests in a timely manner," said MannKind CEO Alfred Mann.

MannKind is seeking FDA approval for Afrezza as a drug/device for the treatment of patients with Type 1 and Type 2 diabetes.

FDA Ok on Amylin Drug Safety

(Updated at 7:15 AM EDT)

U.S. regulators delayed the approval of a new long-acting diabetes drug from Amylin Pharmaceuticals ( AMLN) and Eli Lilly ( LLY) to finalize the medicine's label and to clarify manufacturing.

While the U.S. Food and Drug Administration failed to approve Bydureon (previously known as exenatide once-weekly) Friday, the agency did not ask Amylin and Lilly to conduct new clinical trials or to submit additional safety data.

Amylin said it would work quickly to submit a response to the FDA's questions in the next few weeks. The company added that concerns about its Ohio manufacturing facility raised by FDA during a December inspection have already been corrected.

"This is a significant step forward in our ability to bring this important therapy to patients," said Dr. Orville Kolterman, Amylin's senior vice president of research and development, in a statement.

Bydureon is a once-weekly formulation of the twice-daily injectable drug Byetta, currently marketed by Amylin and Lilly. Byetta sales total around $700 million, but the more convenient Bydureon is expected to bring in well over $1 billion in revenue and be a major growth driver for the companies, according to analysts.

The drug-delivery technology that enables Bydureon to be dosed so infrequently comes from Alkermes ( ALKS), which will receive royalties on sales of the drug when approved.

Bydureon and Novo Nordisk's ( NVO) recently approved Victoza belong to the GLP-1 class of injectable diabetes drugs intended to control blood sugar in Type 2 diabetes medicines. Victoza requires a once-daily injection.

Amylin shares closed Friday at $20.26; Alkermes shares closed at $12.21.

-- Reported by Adam Feuerstein in Boston.

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Adam Feuerstein writes regularly for In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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