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Attention Biotech Investors: Mark Your Calendar For These December PDUFA Dates

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Shanthi Rexaline
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Biotech stocks had a fairly robust November, with the iShares NASDAQ Biotechnology Index (NASDAQ: IBB) advancing over 10% for the month. This compares to the 3% gains for the S&P 500 Index.

The month witnessed eight new molecular entity, or NME, approvals, taking the total NME approvals for the year to 41 compared to 55 approvals by the same time last year.

The FDA approved two drugs for sickle cell disease this month: Novartis AG's (NYSE: NVS) Adakveo as well as Global Blood Therapeutics Inc's (NASDAQ: GBT) Oxbryta.

PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted six months to review the drug. These time frames begin on the date that an NDA is accepted by the FDA as complete.

As we approach the end of the year, here's a look at a few drugs that await FDA's final word in December.

Will Roche's Tecentriq Win FDA Backing For Lung Cancer?

  • Company: Roche Holdings AG Basel ADR (OTC: RHHBY)

  • Type of Application: sBLA

  • Candidate: Tecentriq and Bristol-Myers Squibb Co's (NYSE: BMY) chemo medications Carboplatin and Abraxane

  • Indication: non-squamous non-small cell lung cancer, or NSCLC

  • Date: Dec. 2

Roche's Tecentriq along with chemo combination is being evaluated as a first-line treatment for patients with metastatic non-squamous NSCLC, who do not have EGFR or ALK genomic tumor aberrations.

Following the acceptance of the sBLA with priority review designation in January, the FDA had initially set a PDUFA action date of Sept. 2 which was subsequently extended by three months.

Amgen's Biosimilar For J&J's Inflammation Drug Remicade Awaits FDA Nod

  • Company: Amgen, Inc. (NASDAQ: AMGN)

  • Type of Application: BLA

  • Candidate: ABP 710 or Infliximab biosimilar

  • Indication: migraine in adults

  • Date: Dec. 14 (Biosimilar User Fee Act date)

ABP 710 is a biosimilar candidate to Johnson & Johnson's (NYSE: JNJ) Remicade, which has been approved for multiple indications such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

Amgen had submitted the BLA in December 2018. Incidentally, the company withdrew its European filing for ABP 710 in May, citing a change in product strategy for the pipeline candidate.

D-Day Set For Avadel's AV001 After 3-Month Extension

  • Company: Avadel Pharmaceuticals PLC (NASDAQ: AVDL)

  • Type of Application: NDA

  • Candidate: AV001

  • Indication: Sterile injectable product for the hospital market

  • Date: Dec. 15

The NDA was originally accepted for review in May under Priority Review program, with the decision date fixed for Sept. 15. The FDA extended the review period by three months, requiring time to review submissions related to additional analytical information sought for by the agency. The company maintained its commercial launch schedule intact at the first quarter of 2020.

AV001 is marketed as an unapproved marketed product by another company, and Avadel's development and formulation has improved its safety profile, the company said.

See Also: A Deep Dive Into Aquestive Following The FDA's Approval Of Riluzole

Bausch Health's Acne Treatment

  • Company: Bausch Health Companies Inc (NYSE: BHC)

  • Type of Application: NDA

  • Candidate: IDP-123 (tazarotene 0.045%) lotion

  • Indication: Acne treatment

  • Date: Dec. 22

The FDA accepted the NDA filed by Bausch Health's Ortho Dermatologics subsidiary in August. If approved, IDP-123 is expected to be the first tazarotene treatment available in lotion form.

Can Correvio's Abnormal Heart Rhythm Drug Clear FDA Hurdle?

  • Company: Correvio Pharma Corp (NASDAQ: CORV)'s

  • Type of Application: NDA

  • Candidate: Brinavess

  • Indication: recent onset atrial fibrillation

  • Date: Dec. 24

The FDA has refused to file the initially submitted NDA in August 2017, citing insufficiency of data. Subsequently, the company refiled the application and the agency accepted the application this time around, assigning an FDA decision date of Dec. 24. The FDA also said it will hold an Adcom meeting ahead of the approval.

Brinavess, or vernakalant HCl in intravenous formulation, is an antiarrhythmic drug that's being evaluated for the rapid onset atrial fibrillation to sinus rhythm for non-surgery patients. It has already been approved in Europe, Canada and other countries worldwide.

Inter-Cellular Expects Smooth Sailing For Schizophrenia Drug

  • Company: Intra-Cellular Therapies Inc (NASDAQ: ITCI)

  • Type of Application: NDA

  • Candidate: Lumateperone

  • Indication: Schizophrenia

  • Date: Dec. 27

Lumateperone is Inter-Cellular's lead product candidate that provides selective and simultaneous modulation of serotonin, dopamine and glutamate - three neurotransmitter pathways implicated in severe mental illness.

The initial PDUFA date of Sept. 27 was pushed back by three months after the company provided additional information to the FDA in response to the agency's request related to non-clinical studies. Incidentally, the FDA also cancelled an Adcom meeting scheduled to discuss the NDA.

Later, following a meeting with the FDA, the company said the agency doesn't plan to hold an Adcom meeting.

Amarin's Vascepa Faces Final Hurdle After Unanimous FDA Panel Backing

  • Company: Amarin Corporation plc (NASDAQ: AMRN)

  • Type of Application: sNDA

  • Candidate: Vascepa

  • Indication: Reduce the risk of cardiovascular events

  • Date: Dec. 28

An FDA panel that met in mid-November unanimously recommended approval of Vascepa to reduce the risk of cardiovascular events in high-risk patients.

Pfizer, Astellas Seek Label Expansion For Prostate Cancer Drug

  • Company: Pfizer Inc. (NYSE: PFE) and ASTELLAS PHARMA/ADR (OTC: ALPMY)

  • Type of Application: sNDA

  • Candidate: Xtandi

  • Indication: prostate cancer

  • Date: Fourth quarter

Xtandi capsules is an androgen receptor inhibitor initially approved for the treatment of patients with castration-resistant prostate cancer. The companies are now seeking approval of the drug for metastatic hormone-sensitive prostate cancer.

Can Allergan Get Relief With Migraine Drug Approval?

  • Company: Allergan plc (NYSE: AGN)

  • Type of Application: NDA

  • Candidate: Ubrogepant

  • Indication: migraine in adults

  • Date: Fourth quarter

Ubrogepant is being evaluated for acute treatment of migraine in adults. The company announced FDA acceptance of the NDA in March, with the application submitted based on four clinical trials: two pivotal studies dubbed ACHIEVE 1 and ACHIEVE II and two additional studies.

Adcom Meetings

FDA's Cardiovascular and Renal Drugs Advisory Committee will discuss on Dec. 10 Correvio's NDA for Brinavess, or vernakalant HCl solution, ahead of the Dec. 24 PDUFA action date.

The Dermatologic and Ophthalmic Drugs Advisory Committee is scheduled to meet Dec. 13 to discuss Horizon Pharma Ireland Ltd.'s BLA for teprotumumab solution for intravenous use to treat active thyroid eye disease.


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